TP2 Safety Population – TP2

14:36 Jun 23, 2017
This question was closed without grading. Reason: Other

English to Russian translations [PRO]
Medical - Medical: Pharmaceuticals
English term or phrase: TP2 Safety Population – TP2
TP = treatment period

All-Causality TEAEs (≥1% by Preferred Term in Any Treatment Group), TP2 Safety Population – TP2
All-Causality TEAEs of Special Interest, **TP2 Safety Population – TP2**

Subjects discontinued from
14 (5.0)
10 (7.0)
7 (4.9)
31 (5.5)
treatment due to AEs
Subjects discontinued from
12 (4.3)
6 (4.2)
5 (3.5)
23 (4.1)
study due to AEs
Subjects with temporary
10 (3.6)
11 (7.7)
6 (4.2)
27 (4.8)
discontinuation due to AEs
AEs were graded in accordance with National Cancer Institute Common Terminology Criteria for AEs (CTCAE) Version 4.03.
Grades 1-5 AEs are defined as mild, moderate, severe, life threatening AEs and death related to AEs, respectively.
MedDRA (version 19.1) coding dictionary was applied.
Abbreviations:
AE = adverse event; MedDRA = Medical Dictionary for Regulatory Activities; n = number of subjects; N = number of subjects in the TP2 safety population; SAE = serious adverse event;
TEAEs = treatment-emergent AEs; TP2 = Treatment Period 2.
Table S6.
All-Causality TEAEs (≥1% by Preferred Term in Any Treatment Group), TP2 Safety Population – TP2
SOC and Preferred Term
(MedDRA version 19.1)
PF-06438179/ PF-06438179
(N = 280)
n (%)
Infliximab-EU/ Infliximab-EU
(N = 143)
n (%)
Infliximab-EU/ PF-06438179
(N = 143)
n (%)
Maxim Polukhin
Local time: 07:49


Summary of answers provided
4популяция Т2
Leila Usmanova


Discussion entries: 4





  

Answers


45 mins   confidence: Answerer confidence 4/5Answerer confidence 4/5
tp2 safety population – tp2
популяция Т2


Explanation:
Популяция 2-го периода лечения

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Note added at 1 hr (2017-06-23 15:50:26 GMT)
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Уточнение
Популяция для оценки безопасности Т2

Leila Usmanova
Local time: 07:49
Specializes in field
Native speaker of: Russian
PRO pts in category: 2661
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