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Tookad · 4.8 · 8 System organ class Frequency Adverse reaction Reproductive system and Very common Perineal pain9 breast diso
Eintrag öffnenTookad · 4.8 · Additional adverse reactions in the Phase II prostate cancer studies and special authorisation
Eintrag öffnenTookad · 4.8 · Description of selected adverse reactions
Eintrag öffnenTookad · 4.8 · Erectile dysfunction In the Phase III European study, 60 (30.5 %) of patients in the TOOKAD-VTP arm experience
Eintrag öffnenTookad · 4.8 · Extraprostatic necrosis Two cases of excessive extraprostatic necrosis occurred due to incorrect laser calibra
Eintrag öffnenTookad · 4.8 · Genito-urinary infections The most common infections are orchitis, epididymitis and urinary tract infections i
Eintrag öffnenTookad · 4.8 · Perineal injury, perineal pain and prostatitis Perineal injury and perineal pain occurred in 46 (23.4 %) patie
Eintrag öffnenTookad · 4.8 · Prostatic abscess One serious adverse reaction of prostatic abscess which was considered severe was reported i
Eintrag öffnenTookad · 4.8 · Prostatitis occurred in 7 (3.6 %) patients in the controlled Phase III European study. One patient had Grade 3
Eintrag öffnenTookad · 4.8 · Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medi
Eintrag öffnenTookad · 4.8 · Summary of the safety profile The most frequently reported adverse reactions in the Phase II and III clinical
Eintrag öffnenTookad · 4.8 · System organ class Frequency Adverse reaction Infections and infestations Common Genito-urinary tract infectio
Eintrag öffnenTookad · 4.8 · Tabulated list of adverse reactions Adverse reactions reported are listed below in Table 1 by organ class and
Eintrag öffnenTookad · 4.8 · The following terms represent a group of adverse reactions that describes a medical condition rather than a si
Eintrag öffnenTookad · 4.8 · Unspecific adverse events probably linked to the general anaesthesia were also observed: transient global amne
Eintrag öffnenTookad · 4.8 · Urethral stenosis In the pivotal Phase III European study, moderate or severe urethral stenosis developed in 2
Eintrag öffnenTookad · 4.8 · Urinary incontinence In the Phase III European study, 25 (12.7 %) patients experienced urinary incontinence (i
Eintrag öffnenTookad · 4.8 · Urinary retention In the Phase III European study, 30 (15.2 %) patients experienced urinary retention. The med
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