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Exakte Wirkstoffkennungen und zitierbare Passagen zu Wechselwirkungen, Gegenanzeigen und Nebenwirkungen.

Ein Paarvergleich findet Originalpassagen, die den anderen Wirkstoff wörtlich nennen. Aussagen gelten für das jeweilige Präparat und seine Formulierung. Klassenbegriffe und abweichende Synonyme können fehlen. Kein Treffer bedeutet nicht, dass keine Wechselwirkung besteht.

RxNorm 05-Oct-2026 · geprüft 2026-10-27 · 1381 Präparate · 72104 Quellenpassagen · 204 strukturierte Aussagen. Automatisch aktualisiert, ohne menschliche Freigabe.

Quellenpassagen (97)

Nebenwirkungen · Arsenic trioxide Accord

Arsenic trioxide Accord 1 mg/ml concentrate for solution for infusion · Abschnitt 4.8 · PDF-Seite 7–8

HOS-293198 · Präparat HOS-287836

7 hypokalaemia, neutropenia, and increased alanine amino transferase (ALT). Leucocytosis occurred in 50% of patients with relapsed/refractory APL, as determined by haematology assessments.

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

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Version 2026-03-13T10:03:00Z · SHA-256 7e12af9ddb3c21e71d6bde468f903ac44f6080f4f47633520887009a5dad2924 · Passage f36b2bdc7ad8fede5714e4ae60b40988f9cf54005c4f43d255323689fb0573eb · Zeichen 261–450 im Abschnitt

Nebenwirkungen · Arsenic trioxide Accord

Arsenic trioxide Accord 1 mg/ml concentrate for solution for infusion · Abschnitt 4.8 · PDF-Seite 8

HOS-293199 · Präparat HOS-287836

Serious adverse reactions were common (1-10%) and not unexpected in the relapsed/refractory population. Those serious adverse reactions attributed to arsenic trioxide included APL differentiation syndrome (3), leucocytosis (3), prolonged QT interval (4, 1 with torsade de pointes), atrial fibrillation/atrial flutter (1), hyperglycaemia (2) and a variety of serious adverse reactions related to haemorrhage, infections, pain, diarrhoea, nausea.

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

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Version 2026-03-13T10:03:00Z · SHA-256 7e12af9ddb3c21e71d6bde468f903ac44f6080f4f47633520887009a5dad2924 · Passage 58d84321d6d65d17082ab37aa00b4693982afc62243749696b420947953bb13d · Zeichen 452–896 im Abschnitt

Nebenwirkungen · Arsenic trioxide Accord

Arsenic trioxide Accord 1 mg/ml concentrate for solution for infusion · Abschnitt 4.8 · PDF-Seite 8

HOS-293200 · Präparat HOS-287836

In general, treatment-emergent adverse events tended to decrease over time, in relapsed/refractory APL patients perhaps accounted for by amelioration of the underlying disease process. Patients tended to tolerate consolidation and maintenance treatment with less toxicity than in induction. This is probably due to the confounding of adverse events by the uncontrolled disease process early on in the treatment course and the myriad concomitant medicinal products required to control symptoms and morbidity.

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

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Version 2026-03-13T10:03:00Z · SHA-256 7e12af9ddb3c21e71d6bde468f903ac44f6080f4f47633520887009a5dad2924 · Passage f44d498b03b4726954a257949862414ea2bdc8433a0d21562acc134be9f5802f · Zeichen 898–1405 im Abschnitt

Nebenwirkungen · Arsenic trioxide Accord

Arsenic trioxide Accord 1 mg/ml concentrate for solution for infusion · Abschnitt 4.8 · PDF-Seite 8

HOS-293201 · Präparat HOS-287836

In a phase 3, multicentre, non-inferiority trial comparing all-trans-retinoic acid (ATRA) plus chemotherapy with ATRA plus arsenic trioxide in newly diagnosed low-to-intermediate risk APL patients (Study APL0406; see also section 5.1), serious adverse reactions including hepatic toxicity, thrombocytopenia, neutropenia and QTc prolongation were observed in patients treated with arsenic trioxide.

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

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Version 2026-03-13T10:03:00Z · SHA-256 7e12af9ddb3c21e71d6bde468f903ac44f6080f4f47633520887009a5dad2924 · Passage 0544e8a76eee8490a3385ce52dceafa947223faee6ca13e2a8b495f49341390d · Zeichen 1407–1804 im Abschnitt

Nebenwirkungen · Arsenic trioxide Accord

Arsenic trioxide Accord 1 mg/ml concentrate for solution for infusion · Abschnitt 4.8 · PDF-Seite 8

HOS-293202 · Präparat HOS-287836

Tabulated list of adverse reactions

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

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Version 2026-03-13T10:03:00Z · SHA-256 7e12af9ddb3c21e71d6bde468f903ac44f6080f4f47633520887009a5dad2924 · Passage d51c90b617391dca447a849e03c6ddac1785fb6a36da5cf3e36f8f60e5aed8a9 · Zeichen 1806–1841 im Abschnitt

Nebenwirkungen · Arsenic trioxide Accord

Arsenic trioxide Accord 1 mg/ml concentrate for solution for infusion · Abschnitt 4.8 · PDF-Seite 8

HOS-293203 · Präparat HOS-287836

The following undesirable effects have been reported in the APL0406 study in newly diagnosed patients and in clinical trials and/or post-marketing experience in relapsed/refractory APL patients. Undesirable effects are listed in table 2 below as MedDRA preferred term by system organ class and frequencies observed during arsenic trioxide clinical trials in 52 patients with refractory/relapsed APL. Frequencies are defined as: (very common ≥ 1/10), (common ≥ 1/100 to < 1/10), (uncommon ≥ 1/1,000 to < 1/100), not known (cannot be estimated from available data).

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

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Version 2026-03-13T10:03:00Z · SHA-256 7e12af9ddb3c21e71d6bde468f903ac44f6080f4f47633520887009a5dad2924 · Passage eabd217585eb031a03cf8757b1e63b0031567421c42ac5bec64dd2e0d30a07dc · Zeichen 1843–2406 im Abschnitt

Nebenwirkungen · Arsenic trioxide Accord

Arsenic trioxide Accord 1 mg/ml concentrate for solution for infusion · Abschnitt 4.8 · PDF-Seite 8

HOS-293204 · Präparat HOS-287836

Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

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Version 2026-03-13T10:03:00Z · SHA-256 7e12af9ddb3c21e71d6bde468f903ac44f6080f4f47633520887009a5dad2924 · Passage f0aea31bc762ee47d7c3019b5d8f9a5d214553f32e58645ef68cd2f716366f28 · Zeichen 2408–2509 im Abschnitt

Nebenwirkungen · Arsenic trioxide Accord

Arsenic trioxide Accord 1 mg/ml concentrate for solution for infusion · Abschnitt 4.8 · PDF-Seite 8–10

HOS-293205 · Präparat HOS-287836

All grades Grades ≥ 3 Infections and infestations Herpes zoster Common Not known Sepsis Not known Not known Pneumonia Not known Not known Blood and lymphatic system disorders Febrile neutropenia Common Common Leukocytosis Common Common Neutropenia Common Common Pancytopenia Common Common Thrombocytopenia Common Common Anaemia Common Not known Leukopenia Not known Not known Lymphopenia Not known Not known Metabolism and nutrition disorders Hyperglycaemia Very common Very common Hypokalaemia Very common Very common Hypomagnesaemia Very common Common Hypernatraemia Common Common 8 All grades Grades ≥ 3 Ketoacidosis Common Common Hypermagnesaemia Common Not known Dehydration Not known Not known Fluid retention Not known Not known Psychiatric disorders Confusional state Not known Not known Nervous system disorders Paraesthesia Very common Common Dizziness Very common Not known Headache Very common Not known Convulsion Common Not known Encephalopathy, Wernicke Not known Not known encephalopathy Eye disorders Vision blurred Common Not known Cardiac disorders Tachycardia Very common Common Pericardial effusion Common Common Ventricular extrasystoles Common Not known Cardiac failure Not known Not known Ventricular tachycardia Not known Not known Vascular disorders Vasculitis Common Common Hypotension Common Not known Respiratory, thoracic and mediastinal disorders Differentiation syndrome Very common Very common Dyspnoea Very common Common Hypoxia Common Common Pleural effusion Common Common Pleuritic pain Common Common Pulmonary alveolar Common Common haemorrhage Pneumonitis Not known Not known Gastrointestinal disorders Diarrhoea Very common Common Vomiting Very common Not known Nausea Very common Not known Abdominal pain Common Common Skin and subcutaneous tissue disorders Pruritus Very common Not known Rash Very common Not known Erythema Common Common Face oedema Common Not known Musculoskeletal and connective tissue disorders Myalgia Very common Common Arthralgia Common Common Bone pain Common Common Renal and urinary disorders Renal failure Common Not known General disorders and administration site conditions Pyrexia Very common Common Pain Very common Common 9 All grades Grades ≥ 3 Fatigue Very common Not known Oedema Very common Not known Chest pain Common Common Chills Common Not known Investigations Alanine amino transferase Very common Common increased Aspartate amino transferase Very common Common increased Electrocardiogram QT Very common Common prolonged Hyperbilirubinaemia Common Common Blood creatinine increased Common Not known Weight increased Common Not known Gamma-glutamyltransferase Not known* Not known* increased*

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

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Version 2026-03-13T10:03:00Z · SHA-256 7e12af9ddb3c21e71d6bde468f903ac44f6080f4f47633520887009a5dad2924 · Passage 739774918b42448d6637af446b78764f8ba077d7bd2b815dcf4f88896d856bd4 · Zeichen 2564–7905 im Abschnitt

Nebenwirkungen · Arsenic trioxide Accord

Arsenic trioxide Accord 1 mg/ml concentrate for solution for infusion · Abschnitt 4.8 · PDF-Seite 10

HOS-293206 · Präparat HOS-287836

*In the CALGB study C9710, 2 cases of grade ≥3 increased GGT were reported out of the 200 patients who received arsenic trioxide consolidation cycles (cycle 1 and cycle 2) versus none in the control arm.

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

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Version 2026-03-13T10:03:00Z · SHA-256 7e12af9ddb3c21e71d6bde468f903ac44f6080f4f47633520887009a5dad2924 · Passage e0620759b8e0adb946999651acb666d051128b1d2f59d0072e8461ff5c49f761 · Zeichen 7907–8110 im Abschnitt

Nebenwirkungen · Arsenic trioxide Accord

Arsenic trioxide Accord 1 mg/ml concentrate for solution for infusion · Abschnitt 4.8 · PDF-Seite 10

HOS-293207 · Präparat HOS-287836

Description of selected adverse reactions

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

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Version 2026-03-13T10:03:00Z · SHA-256 7e12af9ddb3c21e71d6bde468f903ac44f6080f4f47633520887009a5dad2924 · Passage f66db2a8100a521c1dea72ff90e696fa3846f9d5fcd6cf8e5e03ce5d71bde4a7 · Zeichen 8112–8153 im Abschnitt

Nebenwirkungen · Arsenic trioxide Accord

Arsenic trioxide Accord 1 mg/ml concentrate for solution for infusion · Abschnitt 4.8 · PDF-Seite 10

HOS-293208 · Präparat HOS-287836

Differentiation syndrome During arsenic trioxide treatment, 14 of the 52 patients in the APL studies in the relapsed setting had one or more symptoms of APL differentiation syndrome, characterised by fever, dyspnoea, weight gain, pulmonary infiltrates and pleural or pericardial effusions, with or without leucocytosis (see section 4.4). Twenty-seven patients had leucocytosis (WBC  10 x 103/l) during induction, 4 of whom had values above 100,000/l. Baseline white blood cell (WBC) counts did not correlate with development of leucocytosis on study, and WBC counts during consolidation therapy were not as high as during induction. In these studies, leucocytosis was not treated with chemotherapeutic medicinal products. Medicinal products that are used to lower the white blood cell count often exacerbate the toxicities associated with leucocytosis, and no standard approach has proven effective. One patient treated under a compassionate use program died from cerebral infarct due to leucocytosis, following treatment with chemotherapeutic medicinal products to lower WBC count. Observation is the recommended approach with intervention only in selected cases.

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

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Version 2026-03-13T10:03:00Z · SHA-256 7e12af9ddb3c21e71d6bde468f903ac44f6080f4f47633520887009a5dad2924 · Passage 6993d9b243ce4923e5ce719d9cf1bfeb1ce79cf0dae90bf517788a4a48cec4b8 · Zeichen 8155–9322 im Abschnitt

Nebenwirkungen · Arsenic trioxide Accord

Arsenic trioxide Accord 1 mg/ml concentrate for solution for infusion · Abschnitt 4.8 · PDF-Seite 10

HOS-293209 · Präparat HOS-287836

Mortality in the pivotal studies in the relapsed setting from disseminated intravascular coagulation (DIC) associated haemorrhage was very common (> 10%), which is consistent with the early mortality reported in the literature.

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

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Version 2026-03-13T10:03:00Z · SHA-256 7e12af9ddb3c21e71d6bde468f903ac44f6080f4f47633520887009a5dad2924 · Passage 4534232afa8b7cfb93b0b07fbf4dce896e825d5095012a042be53519126be0f0 · Zeichen 9324–9551 im Abschnitt

Nebenwirkungen · Arsenic trioxide Accord

Arsenic trioxide Accord 1 mg/ml concentrate for solution for infusion · Abschnitt 4.8 · PDF-Seite 10

HOS-293210 · Präparat HOS-287836

In newly diagnosed patients with low to intermediate risk APL, differentiation syndrome was observed in 19 % including 5 severe cases.

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

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Version 2026-03-13T10:03:00Z · SHA-256 7e12af9ddb3c21e71d6bde468f903ac44f6080f4f47633520887009a5dad2924 · Passage 0a8ff3d93bd48522094d22f19a1ebf985635ceaedea94292541a341d09df99c3 · Zeichen 9553–9687 im Abschnitt

Nebenwirkungen · Arsenic trioxide Accord

Arsenic trioxide Accord 1 mg/ml concentrate for solution for infusion · Abschnitt 4.8 · PDF-Seite 10

HOS-293211 · Präparat HOS-287836

In post marketing experience, a differentiation syndrome, like retinoic acid syndrome, has also been reported for the treatment of malignancies other than APL with arsenic trioxide.

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

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Version 2026-03-13T10:03:00Z · SHA-256 7e12af9ddb3c21e71d6bde468f903ac44f6080f4f47633520887009a5dad2924 · Passage 728db79eaa359e15ebf4ea23eabc6f452bc1ab27830b64f65e0929aefbce5ad9 · Zeichen 9689–9870 im Abschnitt

Nebenwirkungen · Arsenic trioxide Accord

Arsenic trioxide Accord 1 mg/ml concentrate for solution for infusion · Abschnitt 4.8 · PDF-Seite 10

HOS-293212 · Präparat HOS-287836

QT interval prolongation Arsenic trioxide can cause QT interval prolongation (see section 4.4). QT prolongation can lead to a torsade de pointes-type ventricular arrhythmia, which can be fatal. The risk of torsade de pointes is related to the extent of QT prolongation, concomitant administration of QT prolonging medicinal products, a history of torsade de pointes, pre-existing QT interval prolongation, congestive heart failure, administration of potassium-wasting diuretics, or other conditions that result in hypokalaemia

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

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Version 2026-03-13T10:03:00Z · SHA-256 7e12af9ddb3c21e71d6bde468f903ac44f6080f4f47633520887009a5dad2924 · Passage a5366304f2f5d2c73f3fa2afb4a9dfe9bafd9ba133fb163e09be80491a4aeac8 · Zeichen 9872–10398 im Abschnitt

Nebenwirkungen · Arsenic trioxide Accord

Arsenic trioxide Accord 1 mg/ml concentrate for solution for infusion · Abschnitt 4.8 · PDF-Seite 10–11

HOS-293213 · Präparat HOS-287836

10 or hypomagnesaemia. One patient (receiving multiple, concomitant medicinal products, including amphotericin B) had asymptomatic torsade de pointes during induction therapy for relapsed APL with arsenic trioxide. She went onto consolidation without further evidence of QT prolongation.

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

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Version 2026-03-13T10:03:00Z · SHA-256 7e12af9ddb3c21e71d6bde468f903ac44f6080f4f47633520887009a5dad2924 · Passage 4ad4cb22659090d89bcd9a64194e6f107699b095ea35e9961363badd2fb421d1 · Zeichen 10451–10739 im Abschnitt

Nebenwirkungen · Arsenic trioxide Accord

Arsenic trioxide Accord 1 mg/ml concentrate for solution for infusion · Abschnitt 4.8 · PDF-Seite 11

HOS-293214 · Präparat HOS-287836

In newly diagnosed patients, with low to intermediate risk APL, QTc prolongation was observed in 15.6 %. In one patient induction treatment was terminated because of severe prolongation of the QTc interval and electrolyte abnormalities on day 3.

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

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Version 2026-03-13T10:03:00Z · SHA-256 7e12af9ddb3c21e71d6bde468f903ac44f6080f4f47633520887009a5dad2924 · Passage c75e14573a428b2ad5430e6a8fee3f00d341b215f8c10424a8a88322313b9d5b · Zeichen 10741–10986 im Abschnitt

Nebenwirkungen · Arsenic trioxide Accord

Arsenic trioxide Accord 1 mg/ml concentrate for solution for infusion · Abschnitt 4.8 · PDF-Seite 11

HOS-293215 · Präparat HOS-287836

Peripheral neuropathy Peripheral neuropathy, characterised by paraesthesia/dysaesthisia, is a common and well known effect of environmental arsenic. Only 2 relapsed/refractory APL patients discontinued treatment early due to this adverse event and one went on to receive additional arsenic trioxide on a subsequent protocol. Forty-four per cent of relapsed/refractory APL patients experienced symptoms that could be associated with neuropathy; most were mild to moderate and were reversible upon cessation of treatment with arsenic trioxide.

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

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Version 2026-03-13T10:03:00Z · SHA-256 7e12af9ddb3c21e71d6bde468f903ac44f6080f4f47633520887009a5dad2924 · Passage bf61183cb74296b68ff1ec8327320624a30f0b605e8bba5d953320d3cb27cc75 · Zeichen 10988–11529 im Abschnitt

Nebenwirkungen · Arsenic trioxide Accord

Arsenic trioxide Accord 1 mg/ml concentrate for solution for infusion · Abschnitt 4.8 · PDF-Seite 11

HOS-293216 · Präparat HOS-287836

Hepatotoxicity (grade 3-4) In newly diagnosed patients with low to intermediate risk APL 63.2 % developed grade 3 or 4 hepatic toxic effects during induction or consolidation treatment with arsenic trioxide in combination with ATRA. However, toxic effects resolved with temporary discontinuation of either arsenic trioxide, ATRA or both (see section 4.4).

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

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Version 2026-03-13T10:03:00Z · SHA-256 7e12af9ddb3c21e71d6bde468f903ac44f6080f4f47633520887009a5dad2924 · Passage 90bbf2af8bc8a4f0b88f5bfcf91ff22b58cb38dee4494599318372fe4d59a152 · Zeichen 11531–11886 im Abschnitt

Nebenwirkungen · Arsenic trioxide Accord

Arsenic trioxide Accord 1 mg/ml concentrate for solution for infusion · Abschnitt 4.8 · PDF-Seite 11

HOS-293217 · Präparat HOS-287836

Haematological and gastrointestinal toxicity In newly diagnosed patients with low to intermediate risk APL, gastrointestinal toxicity, grade 3-4 neutropenia and grade 3 or 4 thrombocytopenia occurred, however these were 2.2 times less frequent in patients treated with arsenic trioxide in combination with ATRA compared to patients treated with ATRA + chemotherapy.

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

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Version 2026-03-13T10:03:00Z · SHA-256 7e12af9ddb3c21e71d6bde468f903ac44f6080f4f47633520887009a5dad2924 · Passage 7b489b56521b4acc2f3ec7c24c59c048702b5442a560d6841fabb006a90ef90c · Zeichen 11888–12253 im Abschnitt

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