Trial Outcomes & Findings for Study of Adding AMG 479 to First Line Chemotherapy in Patients With Optimally Debulked Epithelial Ovarian Cancer (NCT NCT00718523)

Last Updated: 2016-01-12

Results Overview

A patient may have been declared to have progressive disease on the basis of radiological measuremt of tumor lesions assessmt or CA125 evaluation (tumor measuremts taking precedence).Radiological progression was defined as per the RECIST guidelines (Therasse et al, JNCI2000) as at least 20% increase in the sum of the longest diameters of target lesions(ref the smallest sum of the longest diam recorded since the treatmt started or since the appearance of at least 1 new lesion).Serum CA125 progression was defined, according to the 2005 GCIG def: pts with: * Elevated CA125 pretreatmt and normalization of CA125 has to show evidence of CA125≥ 2 times the upper normal limit on 2 occasions at least 1 wk apart OR * Elevated CA125 pretreatmt which never normalized must show evidence of CA125≥ 2 times the nadir value on 2 occasions at least 1 wk apart OR * CA125 in the normal range pretreatmt had to show evidence of CA125 ≥ 2 times the upper normal limit on 2 occasions at least 1 wk apart

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

170 participants

Primary outcome timeframe

Radiological tumor assessment: every 12(+/- 1) weeks for 3 years after randomization + CA 125: day 1 of each cycle

Results posted on

2016-01-12

Participant Flow

The study was conducted over a total of 55 sites in 8 countries.

Participant milestones

Participant milestones
Measure	A Control Placebo plus paclitaxel/carboplatin chemotherapy administered on Day 1 of each 21-day cycle for 6 cycles - then 6 additional cycles of placebo administered on Day 1 of each 21-day cycle. AMG 479 Placebo: Matching placebo administered Day 1 of each 21 day cycle.	B Experimental AMG 479 plus paclitaxel/carboplatin chemotherapy administered on Day 1 of each 21-day cycle for 6 cycles - then 6 additional cycles of AMG 479 single agent administered on Day 1 of each 21-day cycle. AMG 479: Solution for infusion - 18 mg/kg on day 1 of each 21-day cycle
Overall Study STARTED	84	86
Overall Study COMPLETED	66	62
Overall Study NOT COMPLETED	18	24

Reasons for withdrawal

Reasons for withdrawal
Measure	A Control Placebo plus paclitaxel/carboplatin chemotherapy administered on Day 1 of each 21-day cycle for 6 cycles - then 6 additional cycles of placebo administered on Day 1 of each 21-day cycle. AMG 479 Placebo: Matching placebo administered Day 1 of each 21 day cycle.	B Experimental AMG 479 plus paclitaxel/carboplatin chemotherapy administered on Day 1 of each 21-day cycle for 6 cycles - then 6 additional cycles of AMG 479 single agent administered on Day 1 of each 21-day cycle. AMG 479: Solution for infusion - 18 mg/kg on day 1 of each 21-day cycle
Overall Study Withdrawal by Subject	5	7
Overall Study Death	13	17

Baseline Characteristics

Study of Adding AMG 479 to First Line Chemotherapy in Patients With Optimally Debulked Epithelial Ovarian Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	A Control n=84 Participants Placebo plus paclitaxel/carboplatin chemotherapy administered on Day 1 of each 21-day cycle for 6 cycles - then 6 additional cycles of placebo administered on Day 1 of each 21-day cycle. AMG 479 Placebo: Matching placebo administered Day 1 of each 21 day cycle.	B Experimental n=86 Participants AMG 479 plus paclitaxel/carboplatin chemotherapy administered on Day 1 of each 21-day cycle for 6 cycles - then 6 additional cycles of AMG 479 single agent administered on Day 1 of each 21-day cycle. AMG 479: Solution for infusion - 18 mg/kg on day 1 of each 21-day cycle	Total n=170 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	59 Participants n=5 Participants	61 Participants n=7 Participants	120 Participants n=5 Participants
Age, Categorical >=65 years	25 Participants n=5 Participants	25 Participants n=7 Participants	50 Participants n=5 Participants
Age, Continuous	58.1 years STANDARD_DEVIATION 10.0 • n=5 Participants	57.2 years STANDARD_DEVIATION 12.3 • n=7 Participants	57.6 years STANDARD_DEVIATION 11.2 • n=5 Participants
Sex: Female, Male Female	84 Participants n=5 Participants	86 Participants n=7 Participants	170 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	25 participants n=5 Participants	34 participants n=7 Participants	59 participants n=5 Participants
Region of Enrollment United Kingdom	1 participants n=5 Participants	2 participants n=7 Participants	3 participants n=5 Participants
Region of Enrollment Canada	4 participants n=5 Participants	6 participants n=7 Participants	10 participants n=5 Participants
Region of Enrollment France	7 participants n=5 Participants	3 participants n=7 Participants	10 participants n=5 Participants
Region of Enrollment Israel	2 participants n=5 Participants	2 participants n=7 Participants	4 participants n=5 Participants
Region of Enrollment Spain	1 participants n=5 Participants	1 participants n=7 Participants	2 participants n=5 Participants
Region of Enrollment Germany	44 participants n=5 Participants	38 participants n=7 Participants	82 participants n=5 Participants
Eastern Cooperative Oncology Group Performance Status (ECOG PS) PS 0 (fully active)	36 participants n=5 Participants	32 participants n=7 Participants	68 participants n=5 Participants
Eastern Cooperative Oncology Group Performance Status (ECOG PS) PS 1 (restricted in physically strenuous activity)	43 participants n=5 Participants	46 participants n=7 Participants	89 participants n=5 Participants
Eastern Cooperative Oncology Group Performance Status (ECOG PS) PS2(ambulatory and capable of all selfcare)	5 participants n=5 Participants	6 participants n=7 Participants	11 participants n=5 Participants
Eastern Cooperative Oncology Group Performance Status (ECOG PS) Missing	0 participants n=5 Participants	2 participants n=7 Participants	2 participants n=5 Participants
Time from Surgery to first treatment dose	5.1 weeks STANDARD_DEVIATION 1.2 • n=5 Participants	5.1 weeks STANDARD_DEVIATION 1.4 • n=7 Participants	5.1 weeks STANDARD_DEVIATION 1.3 • n=5 Participants
Time from diagnosis to randomization	5.2 weeks STANDARD_DEVIATION 2.3 • n=5 Participants	5.4 weeks STANDARD_DEVIATION 3.4 • n=7 Participants	5.3 weeks STANDARD_DEVIATION 2.9 • n=5 Participants
Origin of tumor Primary peritoneal	8 participants n=5 Participants	4 participants n=7 Participants	12 participants n=5 Participants
Origin of tumor Fallopian tube	4 participants n=5 Participants	4 participants n=7 Participants	8 participants n=5 Participants
Origin of tumor Ovarian	69 participants n=5 Participants	77 participants n=7 Participants	146 participants n=5 Participants
Origin of tumor Ovarian + Primary peritoneal	0 participants n=5 Participants	1 participants n=7 Participants	1 participants n=5 Participants
Origin of tumor Ovarian + Fallopian tube	2 participants n=5 Participants	0 participants n=7 Participants	2 participants n=5 Participants
Origin of tumor Missing	1 participants n=5 Participants	0 participants n=7 Participants	1 participants n=5 Participants
Stage at first diagnosis (International Federation of Gynecology and Obstetrics (FIGO)) IIIA	3 participants n=5 Participants	2 participants n=7 Participants	5 participants n=5 Participants
Stage at first diagnosis (International Federation of Gynecology and Obstetrics (FIGO)) IIIB	10 participants n=5 Participants	6 participants n=7 Participants	16 participants n=5 Participants
Stage at first diagnosis (International Federation of Gynecology and Obstetrics (FIGO)) IIIC	65 participants n=5 Participants	72 participants n=7 Participants	137 participants n=5 Participants
Stage at first diagnosis (International Federation of Gynecology and Obstetrics (FIGO)) IV	6 participants n=5 Participants	6 participants n=7 Participants	12 participants n=5 Participants
Histopathologic type papillary serous	69 participants n=5 Participants	72 participants n=7 Participants	141 participants n=5 Participants
Histopathologic type mucinous	0 participants n=5 Participants	1 participants n=7 Participants	1 participants n=5 Participants
Histopathologic type endometroid	4 participants n=5 Participants	5 participants n=7 Participants	9 participants n=5 Participants
Histopathologic type clear cell	2 participants n=5 Participants	2 participants n=7 Participants	4 participants n=5 Participants
Histopathologic type mixed	5 participants n=5 Participants	3 participants n=7 Participants	8 participants n=5 Participants
Histopathologic type other	4 participants n=5 Participants	3 participants n=7 Participants	7 participants n=5 Participants
Histologic Grade G1 (well differentiated)	1 participants n=5 Participants	5 participants n=7 Participants	6 participants n=5 Participants
Histologic Grade G2 (moderately differentiated)	15 participants n=5 Participants	18 participants n=7 Participants	33 participants n=5 Participants
Histologic Grade G3 (poorly differentiated)	65 participants n=5 Participants	57 participants n=7 Participants	122 participants n=5 Participants
Histologic Grade Not done	3 participants n=5 Participants	6 participants n=7 Participants	9 participants n=5 Participants
Number of prior therapies 1 therapy	80 participants n=5 Participants	78 participants n=7 Participants	158 participants n=5 Participants
Number of prior therapies 2 therapies	4 participants n=5 Participants	8 participants n=7 Participants	12 participants n=5 Participants
CA 125 status with elevated CA 125	67 participants n=5 Participants	70 participants n=7 Participants	137 participants n=5 Participants
CA 125 status with CA 125 in the normal range	17 participants n=5 Participants	15 participants n=7 Participants	32 participants n=5 Participants
CA 125 status missing	0 participants n=5 Participants	1 participants n=7 Participants	1 participants n=5 Participants

PRIMARY outcome

Timeframe: Radiological tumor assessment: every 12(+/- 1) weeks for 3 years after randomization + CA 125: day 1 of each cycle

Population: Unstratified Intent To Treat

Outcome measures

Outcome measures
Measure	A Control n=84 Participants Placebo plus paclitaxel/carboplatin chemotherapy administered on Day 1 of each 21-day cycle for 6 cycles - then 6 additional cycles of placebo administered on Day 1 of each 21-day cycle. AMG 479 Placebo: Matching placebo administered Day 1 of each 21 day cycle.	B Experimental n=86 Participants AMG 479 plus paclitaxel/carboplatin chemotherapy administered on Day 1 of each 21-day cycle for 6 cycles - then 6 additional cycles of AMG 479 single agent administered on Day 1 of each 21-day cycle. AMG 479: Solution for infusion - 18 mg/kg on day 1 of each 21-day cycle
Progression Free Survival (PFS): Time From Randomization Until Date of Progression or Death.	16.690 months Interval 14.686 to 28.123	15.737 months Interval 12.09 to 21.388

SECONDARY outcome

Timeframe: Radiological tumor assessment: every 12 (+/- 1) weeks for 3 years after randomization + CA125: day 1 of each cycle

Population: Unstratified Intent To Treat

Outcome measures

Outcome measures
Measure	A Control n=84 Participants Placebo plus paclitaxel/carboplatin chemotherapy administered on Day 1 of each 21-day cycle for 6 cycles - then 6 additional cycles of placebo administered on Day 1 of each 21-day cycle. AMG 479 Placebo: Matching placebo administered Day 1 of each 21 day cycle.	B Experimental n=86 Participants AMG 479 plus paclitaxel/carboplatin chemotherapy administered on Day 1 of each 21-day cycle for 6 cycles - then 6 additional cycles of AMG 479 single agent administered on Day 1 of each 21-day cycle. AMG 479: Solution for infusion - 18 mg/kg on day 1 of each 21-day cycle
Time To Progression (TTP): Interval From the Date of Randomization to the Date of Disease Progression	17.840 months Interval 14.784 to 34.037	16.066 months Interval 12.09 to 22.341

SECONDARY outcome

Timeframe: Day 1 of each cycle up to 4 years after randomization

Population: Unstratified Intent To Treat

Interval between the date from randomization to death from any cause whichever came first.

Outcome measures

Outcome measures
Measure	A Control n=84 Participants Placebo plus paclitaxel/carboplatin chemotherapy administered on Day 1 of each 21-day cycle for 6 cycles - then 6 additional cycles of placebo administered on Day 1 of each 21-day cycle. AMG 479 Placebo: Matching placebo administered Day 1 of each 21 day cycle.	B Experimental n=86 Participants AMG 479 plus paclitaxel/carboplatin chemotherapy administered on Day 1 of each 21-day cycle for 6 cycles - then 6 additional cycles of AMG 479 single agent administered on Day 1 of each 21-day cycle. AMG 479: Solution for infusion - 18 mg/kg on day 1 of each 21-day cycle
Overall Survival (OS)	NA months The mean survival time and its standard error were underestimated because the largest observation was censored and the estimation was restricted to the largest event time.	45.207 months Interval 45.207 to The mean survival time and its standard error were underestimated because the largest observation was censored and the estimation was restricted to the largest event time.

Adverse Events

A Control

Serious events: 31 serious events

Other events: 77 other events

Deaths: 0 deaths

B Experimental

Serious events: 30 serious events

Other events: 86 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Additional Information

Matthieu Rupin

Translational Research In Oncology (formerly CIRG)

Phone: +331 58 10 08 89

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Serious adverse events
Measure	A Control n=77 participants at risk Placebo plus paclitaxel/carboplatin chemotherapy administered on Day 1 of each 21-day cycle for 6 cycles - then 6 additional cycles of placebo administered on Day 1 of each 21-day cycle. AMG 479 Placebo: Matching placebo administered Day 1 of each 21 day cycle.	B Experimental n=88 participants at risk AMG 479 plus paclitaxel/carboplatin chemotherapy administered on Day 1 of each 21-day cycle for 6 cycles - then 6 additional cycles of AMG 479 single agent administered on Day 1 of each 21-day cycle. AMG 479: Solution for infusion - 18 mg/kg on day 1 of each 21-day cycle
Blood and lymphatic system disorders Anaemia	1.3% 1/77 • Number of events 1 • The monitoring period for AEs started from signature of the ICF and continued up to 30 days after last dose. For participant flow module it is based on Intent To Treat so the patients are counted according to their "randomization group".For "participants at risk" the patients are grouped by the "actual treatment" 4 patients were allocated with incorrect treatment and received AMG479 instead of Placebo.The total number of patients treated remains the same.	6.8% 6/88 • Number of events 6 • The monitoring period for AEs started from signature of the ICF and continued up to 30 days after last dose. For participant flow module it is based on Intent To Treat so the patients are counted according to their "randomization group".For "participants at risk" the patients are grouped by the "actual treatment" 4 patients were allocated with incorrect treatment and received AMG479 instead of Placebo.The total number of patients treated remains the same.
Blood and lymphatic system disorders Leukopenia	1.3% 1/77 • Number of events 1 • The monitoring period for AEs started from signature of the ICF and continued up to 30 days after last dose. For participant flow module it is based on Intent To Treat so the patients are counted according to their "randomization group".For "participants at risk" the patients are grouped by the "actual treatment" 4 patients were allocated with incorrect treatment and received AMG479 instead of Placebo.The total number of patients treated remains the same.	1.1% 1/88 • Number of events 1 • The monitoring period for AEs started from signature of the ICF and continued up to 30 days after last dose. For participant flow module it is based on Intent To Treat so the patients are counted according to their "randomization group".For "participants at risk" the patients are grouped by the "actual treatment" 4 patients were allocated with incorrect treatment and received AMG479 instead of Placebo.The total number of patients treated remains the same.
Blood and lymphatic system disorders Thrombocytopenia	1.3% 1/77 • Number of events 1 • The monitoring period for AEs started from signature of the ICF and continued up to 30 days after last dose. For participant flow module it is based on Intent To Treat so the patients are counted according to their "randomization group".For "participants at risk" the patients are grouped by the "actual treatment" 4 patients were allocated with incorrect treatment and received AMG479 instead of Placebo.The total number of patients treated remains the same.	5.7% 5/88 • Number of events 7 • The monitoring period for AEs started from signature of the ICF and continued up to 30 days after last dose. For participant flow module it is based on Intent To Treat so the patients are counted according to their "randomization group".For "participants at risk" the patients are grouped by the "actual treatment" 4 patients were allocated with incorrect treatment and received AMG479 instead of Placebo.The total number of patients treated remains the same.
Blood and lymphatic system disorders Neutropenia	0.00% 0/77 • The monitoring period for AEs started from signature of the ICF and continued up to 30 days after last dose. For participant flow module it is based on Intent To Treat so the patients are counted according to their "randomization group".For "participants at risk" the patients are grouped by the "actual treatment" 4 patients were allocated with incorrect treatment and received AMG479 instead of Placebo.The total number of patients treated remains the same.	1.1% 1/88 • Number of events 1 • The monitoring period for AEs started from signature of the ICF and continued up to 30 days after last dose. For participant flow module it is based on Intent To Treat so the patients are counted according to their "randomization group".For "participants at risk" the patients are grouped by the "actual treatment" 4 patients were allocated with incorrect treatment and received AMG479 instead of Placebo.The total number of patients treated remains the same.
Blood and lymphatic system disorders Pancytopenia	0.00% 0/77 • The monitoring period for AEs started from signature of the ICF and continued up to 30 days after last dose. For participant flow module it is based on Intent To Treat so the patients are counted according to their "randomization group".For "participants at risk" the patients are grouped by the "actual treatment" 4 patients were allocated with incorrect treatment and received AMG479 instead of Placebo.The total number of patients treated remains the same.	1.1% 1/88 • Number of events 1 • The monitoring period for AEs started from signature of the ICF and continued up to 30 days after last dose. For participant flow module it is based on Intent To Treat so the patients are counted according to their "randomization group".For "participants at risk" the patients are grouped by the "actual treatment" 4 patients were allocated with incorrect treatment and received AMG479 instead of Placebo.The total number of patients treated remains the same.
Blood and lymphatic system disorders Febrile neutropenia	0.00% 0/77 • The monitoring period for AEs started from signature of the ICF and continued up to 30 days after last dose. For participant flow module it is based on Intent To Treat so the patients are counted according to their "randomization group".For "participants at risk" the patients are grouped by the "actual treatment" 4 patients were allocated with incorrect treatment and received AMG479 instead of Placebo.The total number of patients treated remains the same.	1.1% 1/88 • Number of events 1 • The monitoring period for AEs started from signature of the ICF and continued up to 30 days after last dose. For participant flow module it is based on Intent To Treat so the patients are counted according to their "randomization group".For "participants at risk" the patients are grouped by the "actual treatment" 4 patients were allocated with incorrect treatment and received AMG479 instead of Placebo.The total number of patients treated remains the same.
Gastrointestinal disorders Intestinal obstruction	2.6% 2/77 • Number of events 2 • The monitoring period for AEs started from signature of the ICF and continued up to 30 days after last dose. For participant flow module it is based on Intent To Treat so the patients are counted according to their "randomization group".For "participants at risk" the patients are grouped by the "actual treatment" 4 patients were allocated with incorrect treatment and received AMG479 instead of Placebo.The total number of patients treated remains the same.	3.4% 3/88 • Number of events 4 • The monitoring period for AEs started from signature of the ICF and continued up to 30 days after last dose. For participant flow module it is based on Intent To Treat so the patients are counted according to their "randomization group".For "participants at risk" the patients are grouped by the "actual treatment" 4 patients were allocated with incorrect treatment and received AMG479 instead of Placebo.The total number of patients treated remains the same.
Gastrointestinal disorders Diarrhoea	1.3% 1/77 • Number of events 1 • The monitoring period for AEs started from signature of the ICF and continued up to 30 days after last dose. For participant flow module it is based on Intent To Treat so the patients are counted according to their "randomization group".For "participants at risk" the patients are grouped by the "actual treatment" 4 patients were allocated with incorrect treatment and received AMG479 instead of Placebo.The total number of patients treated remains the same.	1.1% 1/88 • Number of events 1 • The monitoring period for AEs started from signature of the ICF and continued up to 30 days after last dose. For participant flow module it is based on Intent To Treat so the patients are counted according to their "randomization group".For "participants at risk" the patients are grouped by the "actual treatment" 4 patients were allocated with incorrect treatment and received AMG479 instead of Placebo.The total number of patients treated remains the same.
Gastrointestinal disorders Ileus	2.6% 2/77 • Number of events 2 • The monitoring period for AEs started from signature of the ICF and continued up to 30 days after last dose. For participant flow module it is based on Intent To Treat so the patients are counted according to their "randomization group".For "participants at risk" the patients are grouped by the "actual treatment" 4 patients were allocated with incorrect treatment and received AMG479 instead of Placebo.The total number of patients treated remains the same.	2.3% 2/88 • Number of events 3 • The monitoring period for AEs started from signature of the ICF and continued up to 30 days after last dose. For participant flow module it is based on Intent To Treat so the patients are counted according to their "randomization group".For "participants at risk" the patients are grouped by the "actual treatment" 4 patients were allocated with incorrect treatment and received AMG479 instead of Placebo.The total number of patients treated remains the same.
Gastrointestinal disorders Abdominal pain	2.6% 2/77 • Number of events 2 • The monitoring period for AEs started from signature of the ICF and continued up to 30 days after last dose. For participant flow module it is based on Intent To Treat so the patients are counted according to their "randomization group".For "participants at risk" the patients are grouped by the "actual treatment" 4 patients were allocated with incorrect treatment and received AMG479 instead of Placebo.The total number of patients treated remains the same.	1.1% 1/88 • Number of events 1 • The monitoring period for AEs started from signature of the ICF and continued up to 30 days after last dose. For participant flow module it is based on Intent To Treat so the patients are counted according to their "randomization group".For "participants at risk" the patients are grouped by the "actual treatment" 4 patients were allocated with incorrect treatment and received AMG479 instead of Placebo.The total number of patients treated remains the same.
Gastrointestinal disorders Ascites	1.3% 1/77 • Number of events 1 • The monitoring period for AEs started from signature of the ICF and continued up to 30 days after last dose. For participant flow module it is based on Intent To Treat so the patients are counted according to their "randomization group".For "participants at risk" the patients are grouped by the "actual treatment" 4 patients were allocated with incorrect treatment and received AMG479 instead of Placebo.The total number of patients treated remains the same.	0.00% 0/88 • The monitoring period for AEs started from signature of the ICF and continued up to 30 days after last dose. For participant flow module it is based on Intent To Treat so the patients are counted according to their "randomization group".For "participants at risk" the patients are grouped by the "actual treatment" 4 patients were allocated with incorrect treatment and received AMG479 instead of Placebo.The total number of patients treated remains the same.
Gastrointestinal disorders Constipation	1.3% 1/77 • Number of events 1 • The monitoring period for AEs started from signature of the ICF and continued up to 30 days after last dose. For participant flow module it is based on Intent To Treat so the patients are counted according to their "randomization group".For "participants at risk" the patients are grouped by the "actual treatment" 4 patients were allocated with incorrect treatment and received AMG479 instead of Placebo.The total number of patients treated remains the same.	1.1% 1/88 • Number of events 1 • The monitoring period for AEs started from signature of the ICF and continued up to 30 days after last dose. For participant flow module it is based on Intent To Treat so the patients are counted according to their "randomization group".For "participants at risk" the patients are grouped by the "actual treatment" 4 patients were allocated with incorrect treatment and received AMG479 instead of Placebo.The total number of patients treated remains the same.
Gastrointestinal disorders Abdominal Pain Upper	0.00% 0/77 • The monitoring period for AEs started from signature of the ICF and continued up to 30 days after last dose. For participant flow module it is based on Intent To Treat so the patients are counted according to their "randomization group".For "participants at risk" the patients are grouped by the "actual treatment" 4 patients were allocated with incorrect treatment and received AMG479 instead of Placebo.The total number of patients treated remains the same.	1.1% 1/88 • Number of events 1 • The monitoring period for AEs started from signature of the ICF and continued up to 30 days after last dose. For participant flow module it is based on Intent To Treat so the patients are counted according to their "randomization group".For "participants at risk" the patients are grouped by the "actual treatment" 4 patients were allocated with incorrect treatment and received AMG479 instead of Placebo.The total number of patients treated remains the same.
Gastrointestinal disorders Abdominal pain lower	1.3% 1/77 • Number of events 1 • The monitoring period for AEs started from signature of the ICF and continued up to 30 days after last dose. For participant flow module it is based on Intent To Treat so the patients are counted according to their "randomization group".For "participants at risk" the patients are grouped by the "actual treatment" 4 patients were allocated with incorrect treatment and received AMG479 instead of Placebo.The total number of patients treated remains the same.	0.00% 0/88 • The monitoring period for AEs started from signature of the ICF and continued up to 30 days after last dose. For participant flow module it is based on Intent To Treat so the patients are counted according to their "randomization group".For "participants at risk" the patients are grouped by the "actual treatment" 4 patients were allocated with incorrect treatment and received AMG479 instead of Placebo.The total number of patients treated remains the same.
Gastrointestinal disorders Vomiting	1.3% 1/77 • Number of events 1 • The monitoring period for AEs started from signature of the ICF and continued up to 30 days after last dose. For participant flow module it is based on Intent To Treat so the patients are counted according to their "randomization group".For "participants at risk" the patients are grouped by the "actual treatment" 4 patients were allocated with incorrect treatment and received AMG479 instead of Placebo.The total number of patients treated remains the same.	1.1% 1/88 • Number of events 1 • The monitoring period for AEs started from signature of the ICF and continued up to 30 days after last dose. For participant flow module it is based on Intent To Treat so the patients are counted according to their "randomization group".For "participants at risk" the patients are grouped by the "actual treatment" 4 patients were allocated with incorrect treatment and received AMG479 instead of Placebo.The total number of patients treated remains the same.
Gastrointestinal disorders Gastrointestinal Hypomotility	1.3% 1/77 • Number of events 1 • The monitoring period for AEs started from signature of the ICF and continued up to 30 days after last dose. For participant flow module it is based on Intent To Treat so the patients are counted according to their "randomization group".For "participants at risk" the patients are grouped by the "actual treatment" 4 patients were allocated with incorrect treatment and received AMG479 instead of Placebo.The total number of patients treated remains the same.	0.00% 0/88 • The monitoring period for AEs started from signature of the ICF and continued up to 30 days after last dose. For participant flow module it is based on Intent To Treat so the patients are counted according to their "randomization group".For "participants at risk" the patients are grouped by the "actual treatment" 4 patients were allocated with incorrect treatment and received AMG479 instead of Placebo.The total number of patients treated remains the same.
Gastrointestinal disorders Nausea	0.00% 0/77 • The monitoring period for AEs started from signature of the ICF and continued up to 30 days after last dose. For participant flow module it is based on Intent To Treat so the patients are counted according to their "randomization group".For "participants at risk" the patients are grouped by the "actual treatment" 4 patients were allocated with incorrect treatment and received AMG479 instead of Placebo.The total number of patients treated remains the same.	1.1% 1/88 • Number of events 1 • The monitoring period for AEs started from signature of the ICF and continued up to 30 days after last dose. For participant flow module it is based on Intent To Treat so the patients are counted according to their "randomization group".For "participants at risk" the patients are grouped by the "actual treatment" 4 patients were allocated with incorrect treatment and received AMG479 instead of Placebo.The total number of patients treated remains the same.
Gastrointestinal disorders Subileus	1.3% 1/77 • Number of events 1 • The monitoring period for AEs started from signature of the ICF and continued up to 30 days after last dose. For participant flow module it is based on Intent To Treat so the patients are counted according to their "randomization group".For "participants at risk" the patients are grouped by the "actual treatment" 4 patients were allocated with incorrect treatment and received AMG479 instead of Placebo.The total number of patients treated remains the same.	1.1% 1/88 • Number of events 1 • The monitoring period for AEs started from signature of the ICF and continued up to 30 days after last dose. For participant flow module it is based on Intent To Treat so the patients are counted according to their "randomization group".For "participants at risk" the patients are grouped by the "actual treatment" 4 patients were allocated with incorrect treatment and received AMG479 instead of Placebo.The total number of patients treated remains the same.
Gastrointestinal disorders Faecaloma	1.3% 1/77 • Number of events 1 • The monitoring period for AEs started from signature of the ICF and continued up to 30 days after last dose. For participant flow module it is based on Intent To Treat so the patients are counted according to their "randomization group".For "participants at risk" the patients are grouped by the "actual treatment" 4 patients were allocated with incorrect treatment and received AMG479 instead of Placebo.The total number of patients treated remains the same.	0.00% 0/88 • The monitoring period for AEs started from signature of the ICF and continued up to 30 days after last dose. For participant flow module it is based on Intent To Treat so the patients are counted according to their "randomization group".For "participants at risk" the patients are grouped by the "actual treatment" 4 patients were allocated with incorrect treatment and received AMG479 instead of Placebo.The total number of patients treated remains the same.
Gastrointestinal disorders Intestinal infarction	0.00% 0/77 • The monitoring period for AEs started from signature of the ICF and continued up to 30 days after last dose. For participant flow module it is based on Intent To Treat so the patients are counted according to their "randomization group".For "participants at risk" the patients are grouped by the "actual treatment" 4 patients were allocated with incorrect treatment and received AMG479 instead of Placebo.The total number of patients treated remains the same.	1.1% 1/88 • Number of events 1 • The monitoring period for AEs started from signature of the ICF and continued up to 30 days after last dose. For participant flow module it is based on Intent To Treat so the patients are counted according to their "randomization group".For "participants at risk" the patients are grouped by the "actual treatment" 4 patients were allocated with incorrect treatment and received AMG479 instead of Placebo.The total number of patients treated remains the same.
General disorders General Physical health deterioration	1.3% 1/77 • Number of events 1 • The monitoring period for AEs started from signature of the ICF and continued up to 30 days after last dose. For participant flow module it is based on Intent To Treat so the patients are counted according to their "randomization group".For "participants at risk" the patients are grouped by the "actual treatment" 4 patients were allocated with incorrect treatment and received AMG479 instead of Placebo.The total number of patients treated remains the same.	5.7% 5/88 • Number of events 5 • The monitoring period for AEs started from signature of the ICF and continued up to 30 days after last dose. For participant flow module it is based on Intent To Treat so the patients are counted according to their "randomization group".For "participants at risk" the patients are grouped by the "actual treatment" 4 patients were allocated with incorrect treatment and received AMG479 instead of Placebo.The total number of patients treated remains the same.
General disorders non cardiac chest pain	2.6% 2/77 • Number of events 2 • The monitoring period for AEs started from signature of the ICF and continued up to 30 days after last dose. For participant flow module it is based on Intent To Treat so the patients are counted according to their "randomization group".For "participants at risk" the patients are grouped by the "actual treatment" 4 patients were allocated with incorrect treatment and received AMG479 instead of Placebo.The total number of patients treated remains the same.	0.00% 0/88 • The monitoring period for AEs started from signature of the ICF and continued up to 30 days after last dose. For participant flow module it is based on Intent To Treat so the patients are counted according to their "randomization group".For "participants at risk" the patients are grouped by the "actual treatment" 4 patients were allocated with incorrect treatment and received AMG479 instead of Placebo.The total number of patients treated remains the same.
General disorders Asthenia	0.00% 0/77 • The monitoring period for AEs started from signature of the ICF and continued up to 30 days after last dose. For participant flow module it is based on Intent To Treat so the patients are counted according to their "randomization group".For "participants at risk" the patients are grouped by the "actual treatment" 4 patients were allocated with incorrect treatment and received AMG479 instead of Placebo.The total number of patients treated remains the same.	1.1% 1/88 • Number of events 1 • The monitoring period for AEs started from signature of the ICF and continued up to 30 days after last dose. For participant flow module it is based on Intent To Treat so the patients are counted according to their "randomization group".For "participants at risk" the patients are grouped by the "actual treatment" 4 patients were allocated with incorrect treatment and received AMG479 instead of Placebo.The total number of patients treated remains the same.
Infections and infestations Viral infection	0.00% 0/77 • The monitoring period for AEs started from signature of the ICF and continued up to 30 days after last dose. For participant flow module it is based on Intent To Treat so the patients are counted according to their "randomization group".For "participants at risk" the patients are grouped by the "actual treatment" 4 patients were allocated with incorrect treatment and received AMG479 instead of Placebo.The total number of patients treated remains the same.	1.1% 1/88 • Number of events 1 • The monitoring period for AEs started from signature of the ICF and continued up to 30 days after last dose. For participant flow module it is based on Intent To Treat so the patients are counted according to their "randomization group".For "participants at risk" the patients are grouped by the "actual treatment" 4 patients were allocated with incorrect treatment and received AMG479 instead of Placebo.The total number of patients treated remains the same.
Infections and infestations Gastroenteritis	1.3% 1/77 • Number of events 1 • The monitoring period for AEs started from signature of the ICF and continued up to 30 days after last dose. For participant flow module it is based on Intent To Treat so the patients are counted according to their "randomization group".For "participants at risk" the patients are grouped by the "actual treatment" 4 patients were allocated with incorrect treatment and received AMG479 instead of Placebo.The total number of patients treated remains the same.	1.1% 1/88 • Number of events 1 • The monitoring period for AEs started from signature of the ICF and continued up to 30 days after last dose. For participant flow module it is based on Intent To Treat so the patients are counted according to their "randomization group".For "participants at risk" the patients are grouped by the "actual treatment" 4 patients were allocated with incorrect treatment and received AMG479 instead of Placebo.The total number of patients treated remains the same.
Infections and infestations Device related infection	0.00% 0/77 • The monitoring period for AEs started from signature of the ICF and continued up to 30 days after last dose. For participant flow module it is based on Intent To Treat so the patients are counted according to their "randomization group".For "participants at risk" the patients are grouped by the "actual treatment" 4 patients were allocated with incorrect treatment and received AMG479 instead of Placebo.The total number of patients treated remains the same.	3.4% 3/88 • Number of events 3 • The monitoring period for AEs started from signature of the ICF and continued up to 30 days after last dose. For participant flow module it is based on Intent To Treat so the patients are counted according to their "randomization group".For "participants at risk" the patients are grouped by the "actual treatment" 4 patients were allocated with incorrect treatment and received AMG479 instead of Placebo.The total number of patients treated remains the same.
Infections and infestations Tracheobronchitis	0.00% 0/77 • The monitoring period for AEs started from signature of the ICF and continued up to 30 days after last dose. For participant flow module it is based on Intent To Treat so the patients are counted according to their "randomization group".For "participants at risk" the patients are grouped by the "actual treatment" 4 patients were allocated with incorrect treatment and received AMG479 instead of Placebo.The total number of patients treated remains the same.	1.1% 1/88 • Number of events 1 • The monitoring period for AEs started from signature of the ICF and continued up to 30 days after last dose. For participant flow module it is based on Intent To Treat so the patients are counted according to their "randomization group".For "participants at risk" the patients are grouped by the "actual treatment" 4 patients were allocated with incorrect treatment and received AMG479 instead of Placebo.The total number of patients treated remains the same.
Infections and infestations Hepatitis C	0.00% 0/77 • The monitoring period for AEs started from signature of the ICF and continued up to 30 days after last dose. For participant flow module it is based on Intent To Treat so the patients are counted according to their "randomization group".For "participants at risk" the patients are grouped by the "actual treatment" 4 patients were allocated with incorrect treatment and received AMG479 instead of Placebo.The total number of patients treated remains the same.	1.1% 1/88 • Number of events 1 • The monitoring period for AEs started from signature of the ICF and continued up to 30 days after last dose. For participant flow module it is based on Intent To Treat so the patients are counted according to their "randomization group".For "participants at risk" the patients are grouped by the "actual treatment" 4 patients were allocated with incorrect treatment and received AMG479 instead of Placebo.The total number of patients treated remains the same.
Infections and infestations Neutropenic infection	0.00% 0/77 • The monitoring period for AEs started from signature of the ICF and continued up to 30 days after last dose. For participant flow module it is based on Intent To Treat so the patients are counted according to their "randomization group".For "participants at risk" the patients are grouped by the "actual treatment" 4 patients were allocated with incorrect treatment and received AMG479 instead of Placebo.The total number of patients treated remains the same.	2.3% 2/88 • Number of events 2 • The monitoring period for AEs started from signature of the ICF and continued up to 30 days after last dose. For participant flow module it is based on Intent To Treat so the patients are counted according to their "randomization group".For "participants at risk" the patients are grouped by the "actual treatment" 4 patients were allocated with incorrect treatment and received AMG479 instead of Placebo.The total number of patients treated remains the same.
Infections and infestations Bacterial infection	1.3% 1/77 • Number of events 1 • The monitoring period for AEs started from signature of the ICF and continued up to 30 days after last dose. For participant flow module it is based on Intent To Treat so the patients are counted according to their "randomization group".For "participants at risk" the patients are grouped by the "actual treatment" 4 patients were allocated with incorrect treatment and received AMG479 instead of Placebo.The total number of patients treated remains the same.	0.00% 0/88 • The monitoring period for AEs started from signature of the ICF and continued up to 30 days after last dose. For participant flow module it is based on Intent To Treat so the patients are counted according to their "randomization group".For "participants at risk" the patients are grouped by the "actual treatment" 4 patients were allocated with incorrect treatment and received AMG479 instead of Placebo.The total number of patients treated remains the same.
Infections and infestations Streptococcal bacteraemia	1.3% 1/77 • Number of events 1 • The monitoring period for AEs started from signature of the ICF and continued up to 30 days after last dose. For participant flow module it is based on Intent To Treat so the patients are counted according to their "randomization group".For "participants at risk" the patients are grouped by the "actual treatment" 4 patients were allocated with incorrect treatment and received AMG479 instead of Placebo.The total number of patients treated remains the same.	0.00% 0/88 • The monitoring period for AEs started from signature of the ICF and continued up to 30 days after last dose. For participant flow module it is based on Intent To Treat so the patients are counted according to their "randomization group".For "participants at risk" the patients are grouped by the "actual treatment" 4 patients were allocated with incorrect treatment and received AMG479 instead of Placebo.The total number of patients treated remains the same.
Infections and infestations Infection	1.3% 1/77 • Number of events 1 • The monitoring period for AEs started from signature of the ICF and continued up to 30 days after last dose. For participant flow module it is based on Intent To Treat so the patients are counted according to their "randomization group".For "participants at risk" the patients are grouped by the "actual treatment" 4 patients were allocated with incorrect treatment and received AMG479 instead of Placebo.The total number of patients treated remains the same.	0.00% 0/88 • The monitoring period for AEs started from signature of the ICF and continued up to 30 days after last dose. For participant flow module it is based on Intent To Treat so the patients are counted according to their "randomization group".For "participants at risk" the patients are grouped by the "actual treatment" 4 patients were allocated with incorrect treatment and received AMG479 instead of Placebo.The total number of patients treated remains the same.
Infections and infestations Abdominal abscess	1.3% 1/77 • Number of events 1 • The monitoring period for AEs started from signature of the ICF and continued up to 30 days after last dose. For participant flow module it is based on Intent To Treat so the patients are counted according to their "randomization group".For "participants at risk" the patients are grouped by the "actual treatment" 4 patients were allocated with incorrect treatment and received AMG479 instead of Placebo.The total number of patients treated remains the same.	0.00% 0/88 • The monitoring period for AEs started from signature of the ICF and continued up to 30 days after last dose. For participant flow module it is based on Intent To Treat so the patients are counted according to their "randomization group".For "participants at risk" the patients are grouped by the "actual treatment" 4 patients were allocated with incorrect treatment and received AMG479 instead of Placebo.The total number of patients treated remains the same.
Infections and infestations Neutropenic sepsis	0.00% 0/77 • The monitoring period for AEs started from signature of the ICF and continued up to 30 days after last dose. For participant flow module it is based on Intent To Treat so the patients are counted according to their "randomization group".For "participants at risk" the patients are grouped by the "actual treatment" 4 patients were allocated with incorrect treatment and received AMG479 instead of Placebo.The total number of patients treated remains the same.	1.1% 1/88 • Number of events 1 • The monitoring period for AEs started from signature of the ICF and continued up to 30 days after last dose. For participant flow module it is based on Intent To Treat so the patients are counted according to their "randomization group".For "participants at risk" the patients are grouped by the "actual treatment" 4 patients were allocated with incorrect treatment and received AMG479 instead of Placebo.The total number of patients treated remains the same.
Infections and infestations Infected lymphocele	1.3% 1/77 • Number of events 1 • The monitoring period for AEs started from signature of the ICF and continued up to 30 days after last dose. For participant flow module it is based on Intent To Treat so the patients are counted according to their "randomization group".For "participants at risk" the patients are grouped by the "actual treatment" 4 patients were allocated with incorrect treatment and received AMG479 instead of Placebo.The total number of patients treated remains the same.	0.00% 0/88 • The monitoring period for AEs started from signature of the ICF and continued up to 30 days after last dose. For participant flow module it is based on Intent To Treat so the patients are counted according to their "randomization group".For "participants at risk" the patients are grouped by the "actual treatment" 4 patients were allocated with incorrect treatment and received AMG479 instead of Placebo.The total number of patients treated remains the same.
Infections and infestations Respiratory tract infection	1.3% 1/77 • Number of events 1 • The monitoring period for AEs started from signature of the ICF and continued up to 30 days after last dose. For participant flow module it is based on Intent To Treat so the patients are counted according to their "randomization group".For "participants at risk" the patients are grouped by the "actual treatment" 4 patients were allocated with incorrect treatment and received AMG479 instead of Placebo.The total number of patients treated remains the same.	0.00% 0/88 • The monitoring period for AEs started from signature of the ICF and continued up to 30 days after last dose. For participant flow module it is based on Intent To Treat so the patients are counted according to their "randomization group".For "participants at risk" the patients are grouped by the "actual treatment" 4 patients were allocated with incorrect treatment and received AMG479 instead of Placebo.The total number of patients treated remains the same.
Infections and infestations Urinary tract infection	1.3% 1/77 • Number of events 1 • The monitoring period for AEs started from signature of the ICF and continued up to 30 days after last dose. For participant flow module it is based on Intent To Treat so the patients are counted according to their "randomization group".For "participants at risk" the patients are grouped by the "actual treatment" 4 patients were allocated with incorrect treatment and received AMG479 instead of Placebo.The total number of patients treated remains the same.	0.00% 0/88 • The monitoring period for AEs started from signature of the ICF and continued up to 30 days after last dose. For participant flow module it is based on Intent To Treat so the patients are counted according to their "randomization group".For "participants at risk" the patients are grouped by the "actual treatment" 4 patients were allocated with incorrect treatment and received AMG479 instead of Placebo.The total number of patients treated remains the same.
Infections and infestations Pneumonia	1.3% 1/77 • Number of events 1 • The monitoring period for AEs started from signature of the ICF and continued up to 30 days after last dose. For participant flow module it is based on Intent To Treat so the patients are counted according to their "randomization group".For "participants at risk" the patients are grouped by the "actual treatment" 4 patients were allocated with incorrect treatment and received AMG479 instead of Placebo.The total number of patients treated remains the same.	0.00% 0/88 • The monitoring period for AEs started from signature of the ICF and continued up to 30 days after last dose. For participant flow module it is based on Intent To Treat so the patients are counted according to their "randomization group".For "participants at risk" the patients are grouped by the "actual treatment" 4 patients were allocated with incorrect treatment and received AMG479 instead of Placebo.The total number of patients treated remains the same.
Injury, poisoning and procedural complications Femoral neck fracture	2.6% 2/77 • Number of events 2 • The monitoring period for AEs started from signature of the ICF and continued up to 30 days after last dose. For participant flow module it is based on Intent To Treat so the patients are counted according to their "randomization group".For "participants at risk" the patients are grouped by the "actual treatment" 4 patients were allocated with incorrect treatment and received AMG479 instead of Placebo.The total number of patients treated remains the same.	0.00% 0/88 • The monitoring period for AEs started from signature of the ICF and continued up to 30 days after last dose. For participant flow module it is based on Intent To Treat so the patients are counted according to their "randomization group".For "participants at risk" the patients are grouped by the "actual treatment" 4 patients were allocated with incorrect treatment and received AMG479 instead of Placebo.The total number of patients treated remains the same.
Injury, poisoning and procedural complications Anastomotic leak	1.3% 1/77 • Number of events 1 • The monitoring period for AEs started from signature of the ICF and continued up to 30 days after last dose. For participant flow module it is based on Intent To Treat so the patients are counted according to their "randomization group".For "participants at risk" the patients are grouped by the "actual treatment" 4 patients were allocated with incorrect treatment and received AMG479 instead of Placebo.The total number of patients treated remains the same.	0.00% 0/88 • The monitoring period for AEs started from signature of the ICF and continued up to 30 days after last dose. For participant flow module it is based on Intent To Treat so the patients are counted according to their "randomization group".For "participants at risk" the patients are grouped by the "actual treatment" 4 patients were allocated with incorrect treatment and received AMG479 instead of Placebo.The total number of patients treated remains the same.

Other adverse events
Measure	A Control n=77 participants at risk Placebo plus paclitaxel/carboplatin chemotherapy administered on Day 1 of each 21-day cycle for 6 cycles - then 6 additional cycles of placebo administered on Day 1 of each 21-day cycle. AMG 479 Placebo: Matching placebo administered Day 1 of each 21 day cycle.	B Experimental n=88 participants at risk AMG 479 plus paclitaxel/carboplatin chemotherapy administered on Day 1 of each 21-day cycle for 6 cycles - then 6 additional cycles of AMG 479 single agent administered on Day 1 of each 21-day cycle. AMG 479: Solution for infusion - 18 mg/kg on day 1 of each 21-day cycle
Ear and labyrinth disorders Tinnitus	5.2% 4/77 • Number of events 4 • The monitoring period for AEs started from signature of the ICF and continued up to 30 days after last dose. For participant flow module it is based on Intent To Treat so the patients are counted according to their "randomization group".For "participants at risk" the patients are grouped by the "actual treatment" 4 patients were allocated with incorrect treatment and received AMG479 instead of Placebo.The total number of patients treated remains the same.	3.4% 3/88 • Number of events 3 • The monitoring period for AEs started from signature of the ICF and continued up to 30 days after last dose. For participant flow module it is based on Intent To Treat so the patients are counted according to their "randomization group".For "participants at risk" the patients are grouped by the "actual treatment" 4 patients were allocated with incorrect treatment and received AMG479 instead of Placebo.The total number of patients treated remains the same.
Ear and labyrinth disorders Vertigo	5.2% 4/77 • Number of events 4 • The monitoring period for AEs started from signature of the ICF and continued up to 30 days after last dose. For participant flow module it is based on Intent To Treat so the patients are counted according to their "randomization group".For "participants at risk" the patients are grouped by the "actual treatment" 4 patients were allocated with incorrect treatment and received AMG479 instead of Placebo.The total number of patients treated remains the same.	9.1% 8/88 • Number of events 8 • The monitoring period for AEs started from signature of the ICF and continued up to 30 days after last dose. For participant flow module it is based on Intent To Treat so the patients are counted according to their "randomization group".For "participants at risk" the patients are grouped by the "actual treatment" 4 patients were allocated with incorrect treatment and received AMG479 instead of Placebo.The total number of patients treated remains the same.
Eye disorders Vision blurred	5.2% 4/77 • Number of events 4 • The monitoring period for AEs started from signature of the ICF and continued up to 30 days after last dose. For participant flow module it is based on Intent To Treat so the patients are counted according to their "randomization group".For "participants at risk" the patients are grouped by the "actual treatment" 4 patients were allocated with incorrect treatment and received AMG479 instead of Placebo.The total number of patients treated remains the same.	4.5% 4/88 • Number of events 4 • The monitoring period for AEs started from signature of the ICF and continued up to 30 days after last dose. For participant flow module it is based on Intent To Treat so the patients are counted according to their "randomization group".For "participants at risk" the patients are grouped by the "actual treatment" 4 patients were allocated with incorrect treatment and received AMG479 instead of Placebo.The total number of patients treated remains the same.
Gastrointestinal disorders Constipation	36.4% 28/77 • Number of events 33 • The monitoring period for AEs started from signature of the ICF and continued up to 30 days after last dose. For participant flow module it is based on Intent To Treat so the patients are counted according to their "randomization group".For "participants at risk" the patients are grouped by the "actual treatment" 4 patients were allocated with incorrect treatment and received AMG479 instead of Placebo.The total number of patients treated remains the same.	31.8% 28/88 • Number of events 32 • The monitoring period for AEs started from signature of the ICF and continued up to 30 days after last dose. For participant flow module it is based on Intent To Treat so the patients are counted according to their "randomization group".For "participants at risk" the patients are grouped by the "actual treatment" 4 patients were allocated with incorrect treatment and received AMG479 instead of Placebo.The total number of patients treated remains the same.
Gastrointestinal disorders Dry mouth	7.8% 6/77 • Number of events 6 • The monitoring period for AEs started from signature of the ICF and continued up to 30 days after last dose. For participant flow module it is based on Intent To Treat so the patients are counted according to their "randomization group".For "participants at risk" the patients are grouped by the "actual treatment" 4 patients were allocated with incorrect treatment and received AMG479 instead of Placebo.The total number of patients treated remains the same.	12.5% 11/88 • Number of events 13 • The monitoring period for AEs started from signature of the ICF and continued up to 30 days after last dose. For participant flow module it is based on Intent To Treat so the patients are counted according to their "randomization group".For "participants at risk" the patients are grouped by the "actual treatment" 4 patients were allocated with incorrect treatment and received AMG479 instead of Placebo.The total number of patients treated remains the same.
Gastrointestinal disorders Stomatitis	22.1% 17/77 • Number of events 19 • The monitoring period for AEs started from signature of the ICF and continued up to 30 days after last dose. For participant flow module it is based on Intent To Treat so the patients are counted according to their "randomization group".For "participants at risk" the patients are grouped by the "actual treatment" 4 patients were allocated with incorrect treatment and received AMG479 instead of Placebo.The total number of patients treated remains the same.	27.3% 24/88 • Number of events 25 • The monitoring period for AEs started from signature of the ICF and continued up to 30 days after last dose. For participant flow module it is based on Intent To Treat so the patients are counted according to their "randomization group".For "participants at risk" the patients are grouped by the "actual treatment" 4 patients were allocated with incorrect treatment and received AMG479 instead of Placebo.The total number of patients treated remains the same.
General disorders Chills	5.2% 4/77 • Number of events 4 • The monitoring period for AEs started from signature of the ICF and continued up to 30 days after last dose. For participant flow module it is based on Intent To Treat so the patients are counted according to their "randomization group".For "participants at risk" the patients are grouped by the "actual treatment" 4 patients were allocated with incorrect treatment and received AMG479 instead of Placebo.The total number of patients treated remains the same.	11.4% 10/88 • Number of events 12 • The monitoring period for AEs started from signature of the ICF and continued up to 30 days after last dose. For participant flow module it is based on Intent To Treat so the patients are counted according to their "randomization group".For "participants at risk" the patients are grouped by the "actual treatment" 4 patients were allocated with incorrect treatment and received AMG479 instead of Placebo.The total number of patients treated remains the same.
General disorders Fatigue	59.7% 46/77 • Number of events 55 • The monitoring period for AEs started from signature of the ICF and continued up to 30 days after last dose. For participant flow module it is based on Intent To Treat so the patients are counted according to their "randomization group".For "participants at risk" the patients are grouped by the "actual treatment" 4 patients were allocated with incorrect treatment and received AMG479 instead of Placebo.The total number of patients treated remains the same.	55.7% 49/88 • Number of events 55 • The monitoring period for AEs started from signature of the ICF and continued up to 30 days after last dose. For participant flow module it is based on Intent To Treat so the patients are counted according to their "randomization group".For "participants at risk" the patients are grouped by the "actual treatment" 4 patients were allocated with incorrect treatment and received AMG479 instead of Placebo.The total number of patients treated remains the same.
General disorders Oedema peripheral	10.4% 8/77 • Number of events 8 • The monitoring period for AEs started from signature of the ICF and continued up to 30 days after last dose. For participant flow module it is based on Intent To Treat so the patients are counted according to their "randomization group".For "participants at risk" the patients are grouped by the "actual treatment" 4 patients were allocated with incorrect treatment and received AMG479 instead of Placebo.The total number of patients treated remains the same.	5.7% 5/88 • Number of events 5 • The monitoring period for AEs started from signature of the ICF and continued up to 30 days after last dose. For participant flow module it is based on Intent To Treat so the patients are counted according to their "randomization group".For "participants at risk" the patients are grouped by the "actual treatment" 4 patients were allocated with incorrect treatment and received AMG479 instead of Placebo.The total number of patients treated remains the same.
General disorders Pain	11.7% 9/77 • Number of events 10 • The monitoring period for AEs started from signature of the ICF and continued up to 30 days after last dose. For participant flow module it is based on Intent To Treat so the patients are counted according to their "randomization group".For "participants at risk" the patients are grouped by the "actual treatment" 4 patients were allocated with incorrect treatment and received AMG479 instead of Placebo.The total number of patients treated remains the same.	12.5% 11/88 • Number of events 11 • The monitoring period for AEs started from signature of the ICF and continued up to 30 days after last dose. For participant flow module it is based on Intent To Treat so the patients are counted according to their "randomization group".For "participants at risk" the patients are grouped by the "actual treatment" 4 patients were allocated with incorrect treatment and received AMG479 instead of Placebo.The total number of patients treated remains the same.
General disorders Pyrexia	16.9% 13/77 • Number of events 15 • The monitoring period for AEs started from signature of the ICF and continued up to 30 days after last dose. For participant flow module it is based on Intent To Treat so the patients are counted according to their "randomization group".For "participants at risk" the patients are grouped by the "actual treatment" 4 patients were allocated with incorrect treatment and received AMG479 instead of Placebo.The total number of patients treated remains the same.	10.2% 9/88 • Number of events 12 • The monitoring period for AEs started from signature of the ICF and continued up to 30 days after last dose. For participant flow module it is based on Intent To Treat so the patients are counted according to their "randomization group".For "participants at risk" the patients are grouped by the "actual treatment" 4 patients were allocated with incorrect treatment and received AMG479 instead of Placebo.The total number of patients treated remains the same.
Immune system disorders Hypersensitivity	13.0% 10/77 • Number of events 14 • The monitoring period for AEs started from signature of the ICF and continued up to 30 days after last dose. For participant flow module it is based on Intent To Treat so the patients are counted according to their "randomization group".For "participants at risk" the patients are grouped by the "actual treatment" 4 patients were allocated with incorrect treatment and received AMG479 instead of Placebo.The total number of patients treated remains the same.	9.1% 8/88 • Number of events 10 • The monitoring period for AEs started from signature of the ICF and continued up to 30 days after last dose. For participant flow module it is based on Intent To Treat so the patients are counted according to their "randomization group".For "participants at risk" the patients are grouped by the "actual treatment" 4 patients were allocated with incorrect treatment and received AMG479 instead of Placebo.The total number of patients treated remains the same.
Infections and infestations Bronchitis	6.5% 5/77 • Number of events 5 • The monitoring period for AEs started from signature of the ICF and continued up to 30 days after last dose. For participant flow module it is based on Intent To Treat so the patients are counted according to their "randomization group".For "participants at risk" the patients are grouped by the "actual treatment" 4 patients were allocated with incorrect treatment and received AMG479 instead of Placebo.The total number of patients treated remains the same.	2.3% 2/88 • Number of events 2 • The monitoring period for AEs started from signature of the ICF and continued up to 30 days after last dose. For participant flow module it is based on Intent To Treat so the patients are counted according to their "randomization group".For "participants at risk" the patients are grouped by the "actual treatment" 4 patients were allocated with incorrect treatment and received AMG479 instead of Placebo.The total number of patients treated remains the same.
Infections and infestations Cystitis	6.5% 5/77 • Number of events 9 • The monitoring period for AEs started from signature of the ICF and continued up to 30 days after last dose. For participant flow module it is based on Intent To Treat so the patients are counted according to their "randomization group".For "participants at risk" the patients are grouped by the "actual treatment" 4 patients were allocated with incorrect treatment and received AMG479 instead of Placebo.The total number of patients treated remains the same.	2.3% 2/88 • Number of events 2 • The monitoring period for AEs started from signature of the ICF and continued up to 30 days after last dose. For participant flow module it is based on Intent To Treat so the patients are counted according to their "randomization group".For "participants at risk" the patients are grouped by the "actual treatment" 4 patients were allocated with incorrect treatment and received AMG479 instead of Placebo.The total number of patients treated remains the same.
Infections and infestations Nasopharyngitis	15.6% 12/77 • Number of events 13 • The monitoring period for AEs started from signature of the ICF and continued up to 30 days after last dose. For participant flow module it is based on Intent To Treat so the patients are counted according to their "randomization group".For "participants at risk" the patients are grouped by the "actual treatment" 4 patients were allocated with incorrect treatment and received AMG479 instead of Placebo.The total number of patients treated remains the same.	8.0% 7/88 • Number of events 10 • The monitoring period for AEs started from signature of the ICF and continued up to 30 days after last dose. For participant flow module it is based on Intent To Treat so the patients are counted according to their "randomization group".For "participants at risk" the patients are grouped by the "actual treatment" 4 patients were allocated with incorrect treatment and received AMG479 instead of Placebo.The total number of patients treated remains the same.
Investigations Weight increased	2.6% 2/77 • Number of events 2 • The monitoring period for AEs started from signature of the ICF and continued up to 30 days after last dose. For participant flow module it is based on Intent To Treat so the patients are counted according to their "randomization group".For "participants at risk" the patients are grouped by the "actual treatment" 4 patients were allocated with incorrect treatment and received AMG479 instead of Placebo.The total number of patients treated remains the same.	5.7% 5/88 • Number of events 6 • The monitoring period for AEs started from signature of the ICF and continued up to 30 days after last dose. For participant flow module it is based on Intent To Treat so the patients are counted according to their "randomization group".For "participants at risk" the patients are grouped by the "actual treatment" 4 patients were allocated with incorrect treatment and received AMG479 instead of Placebo.The total number of patients treated remains the same.
Metabolism and nutrition disorders Decreased appetite	20.8% 16/77 • Number of events 17 • The monitoring period for AEs started from signature of the ICF and continued up to 30 days after last dose. For participant flow module it is based on Intent To Treat so the patients are counted according to their "randomization group".For "participants at risk" the patients are grouped by the "actual treatment" 4 patients were allocated with incorrect treatment and received AMG479 instead of Placebo.The total number of patients treated remains the same.	13.6% 12/88 • Number of events 14 • The monitoring period for AEs started from signature of the ICF and continued up to 30 days after last dose. For participant flow module it is based on Intent To Treat so the patients are counted according to their "randomization group".For "participants at risk" the patients are grouped by the "actual treatment" 4 patients were allocated with incorrect treatment and received AMG479 instead of Placebo.The total number of patients treated remains the same.
Metabolism and nutrition disorders Hypomagnesaemia	2.6% 2/77 • Number of events 2 • The monitoring period for AEs started from signature of the ICF and continued up to 30 days after last dose. For participant flow module it is based on Intent To Treat so the patients are counted according to their "randomization group".For "participants at risk" the patients are grouped by the "actual treatment" 4 patients were allocated with incorrect treatment and received AMG479 instead of Placebo.The total number of patients treated remains the same.	5.7% 5/88 • Number of events 5 • The monitoring period for AEs started from signature of the ICF and continued up to 30 days after last dose. For participant flow module it is based on Intent To Treat so the patients are counted according to their "randomization group".For "participants at risk" the patients are grouped by the "actual treatment" 4 patients were allocated with incorrect treatment and received AMG479 instead of Placebo.The total number of patients treated remains the same.
Musculoskeletal and connective tissue disorders Back pain	18.2% 14/77 • Number of events 16 • The monitoring period for AEs started from signature of the ICF and continued up to 30 days after last dose. For participant flow module it is based on Intent To Treat so the patients are counted according to their "randomization group".For "participants at risk" the patients are grouped by the "actual treatment" 4 patients were allocated with incorrect treatment and received AMG479 instead of Placebo.The total number of patients treated remains the same.	9.1% 8/88 • Number of events 8 • The monitoring period for AEs started from signature of the ICF and continued up to 30 days after last dose. For participant flow module it is based on Intent To Treat so the patients are counted according to their "randomization group".For "participants at risk" the patients are grouped by the "actual treatment" 4 patients were allocated with incorrect treatment and received AMG479 instead of Placebo.The total number of patients treated remains the same.
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	5.2% 4/77 • Number of events 4 • The monitoring period for AEs started from signature of the ICF and continued up to 30 days after last dose. For participant flow module it is based on Intent To Treat so the patients are counted according to their "randomization group".For "participants at risk" the patients are grouped by the "actual treatment" 4 patients were allocated with incorrect treatment and received AMG479 instead of Placebo.The total number of patients treated remains the same.	0.00% 0/88 • The monitoring period for AEs started from signature of the ICF and continued up to 30 days after last dose. For participant flow module it is based on Intent To Treat so the patients are counted according to their "randomization group".For "participants at risk" the patients are grouped by the "actual treatment" 4 patients were allocated with incorrect treatment and received AMG479 instead of Placebo.The total number of patients treated remains the same.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	6.5% 5/77 • Number of events 6 • The monitoring period for AEs started from signature of the ICF and continued up to 30 days after last dose. For participant flow module it is based on Intent To Treat so the patients are counted according to their "randomization group".For "participants at risk" the patients are grouped by the "actual treatment" 4 patients were allocated with incorrect treatment and received AMG479 instead of Placebo.The total number of patients treated remains the same.	3.4% 3/88 • Number of events 3 • The monitoring period for AEs started from signature of the ICF and continued up to 30 days after last dose. For participant flow module it is based on Intent To Treat so the patients are counted according to their "randomization group".For "participants at risk" the patients are grouped by the "actual treatment" 4 patients were allocated with incorrect treatment and received AMG479 instead of Placebo.The total number of patients treated remains the same.
Musculoskeletal and connective tissue disorders Myalgia	26.0% 20/77 • Number of events 26 • The monitoring period for AEs started from signature of the ICF and continued up to 30 days after last dose. For participant flow module it is based on Intent To Treat so the patients are counted according to their "randomization group".For "participants at risk" the patients are grouped by the "actual treatment" 4 patients were allocated with incorrect treatment and received AMG479 instead of Placebo.The total number of patients treated remains the same.	30.7% 27/88 • Number of events 33 • The monitoring period for AEs started from signature of the ICF and continued up to 30 days after last dose. For participant flow module it is based on Intent To Treat so the patients are counted according to their "randomization group".For "participants at risk" the patients are grouped by the "actual treatment" 4 patients were allocated with incorrect treatment and received AMG479 instead of Placebo.The total number of patients treated remains the same.
Musculoskeletal and connective tissue disorders Pain in extremity	20.8% 16/77 • Number of events 17 • The monitoring period for AEs started from signature of the ICF and continued up to 30 days after last dose. For participant flow module it is based on Intent To Treat so the patients are counted according to their "randomization group".For "participants at risk" the patients are grouped by the "actual treatment" 4 patients were allocated with incorrect treatment and received AMG479 instead of Placebo.The total number of patients treated remains the same.	12.5% 11/88 • Number of events 13 • The monitoring period for AEs started from signature of the ICF and continued up to 30 days after last dose. For participant flow module it is based on Intent To Treat so the patients are counted according to their "randomization group".For "participants at risk" the patients are grouped by the "actual treatment" 4 patients were allocated with incorrect treatment and received AMG479 instead of Placebo.The total number of patients treated remains the same.
Nervous system disorders Dysgueusia	19.5% 15/77 • Number of events 17 • The monitoring period for AEs started from signature of the ICF and continued up to 30 days after last dose. For participant flow module it is based on Intent To Treat so the patients are counted according to their "randomization group".For "participants at risk" the patients are grouped by the "actual treatment" 4 patients were allocated with incorrect treatment and received AMG479 instead of Placebo.The total number of patients treated remains the same.	17.0% 15/88 • Number of events 16 • The monitoring period for AEs started from signature of the ICF and continued up to 30 days after last dose. For participant flow module it is based on Intent To Treat so the patients are counted according to their "randomization group".For "participants at risk" the patients are grouped by the "actual treatment" 4 patients were allocated with incorrect treatment and received AMG479 instead of Placebo.The total number of patients treated remains the same.
Nervous system disorders Headache	22.1% 17/77 • Number of events 20 • The monitoring period for AEs started from signature of the ICF and continued up to 30 days after last dose. For participant flow module it is based on Intent To Treat so the patients are counted according to their "randomization group".For "participants at risk" the patients are grouped by the "actual treatment" 4 patients were allocated with incorrect treatment and received AMG479 instead of Placebo.The total number of patients treated remains the same.	26.1% 23/88 • Number of events 30 • The monitoring period for AEs started from signature of the ICF and continued up to 30 days after last dose. For participant flow module it is based on Intent To Treat so the patients are counted according to their "randomization group".For "participants at risk" the patients are grouped by the "actual treatment" 4 patients were allocated with incorrect treatment and received AMG479 instead of Placebo.The total number of patients treated remains the same.
Nervous system disorders Neuropathy peripheral	19.5% 15/77 • Number of events 17 • The monitoring period for AEs started from signature of the ICF and continued up to 30 days after last dose. For participant flow module it is based on Intent To Treat so the patients are counted according to their "randomization group".For "participants at risk" the patients are grouped by the "actual treatment" 4 patients were allocated with incorrect treatment and received AMG479 instead of Placebo.The total number of patients treated remains the same.	27.3% 24/88 • Number of events 25 • The monitoring period for AEs started from signature of the ICF and continued up to 30 days after last dose. For participant flow module it is based on Intent To Treat so the patients are counted according to their "randomization group".For "participants at risk" the patients are grouped by the "actual treatment" 4 patients were allocated with incorrect treatment and received AMG479 instead of Placebo.The total number of patients treated remains the same.
Nervous system disorders Paraesthesia	9.1% 7/77 • Number of events 9 • The monitoring period for AEs started from signature of the ICF and continued up to 30 days after last dose. For participant flow module it is based on Intent To Treat so the patients are counted according to their "randomization group".For "participants at risk" the patients are grouped by the "actual treatment" 4 patients were allocated with incorrect treatment and received AMG479 instead of Placebo.The total number of patients treated remains the same.	3.4% 3/88 • Number of events 3 • The monitoring period for AEs started from signature of the ICF and continued up to 30 days after last dose. For participant flow module it is based on Intent To Treat so the patients are counted according to their "randomization group".For "participants at risk" the patients are grouped by the "actual treatment" 4 patients were allocated with incorrect treatment and received AMG479 instead of Placebo.The total number of patients treated remains the same.
Nervous system disorders Peripheral sensory neuropathy	41.6% 32/77 • Number of events 35 • The monitoring period for AEs started from signature of the ICF and continued up to 30 days after last dose. For participant flow module it is based on Intent To Treat so the patients are counted according to their "randomization group".For "participants at risk" the patients are grouped by the "actual treatment" 4 patients were allocated with incorrect treatment and received AMG479 instead of Placebo.The total number of patients treated remains the same.	30.7% 27/88 • Number of events 31 • The monitoring period for AEs started from signature of the ICF and continued up to 30 days after last dose. For participant flow module it is based on Intent To Treat so the patients are counted according to their "randomization group".For "participants at risk" the patients are grouped by the "actual treatment" 4 patients were allocated with incorrect treatment and received AMG479 instead of Placebo.The total number of patients treated remains the same.
Nervous system disorders Polyneuropathy	14.3% 11/77 • Number of events 11 • The monitoring period for AEs started from signature of the ICF and continued up to 30 days after last dose. For participant flow module it is based on Intent To Treat so the patients are counted according to their "randomization group".For "participants at risk" the patients are grouped by the "actual treatment" 4 patients were allocated with incorrect treatment and received AMG479 instead of Placebo.The total number of patients treated remains the same.	9.1% 8/88 • Number of events 8 • The monitoring period for AEs started from signature of the ICF and continued up to 30 days after last dose. For participant flow module it is based on Intent To Treat so the patients are counted according to their "randomization group".For "participants at risk" the patients are grouped by the "actual treatment" 4 patients were allocated with incorrect treatment and received AMG479 instead of Placebo.The total number of patients treated remains the same.
Psychiatric disorders Anxiety	5.2% 4/77 • Number of events 4 • The monitoring period for AEs started from signature of the ICF and continued up to 30 days after last dose. For participant flow module it is based on Intent To Treat so the patients are counted according to their "randomization group".For "participants at risk" the patients are grouped by the "actual treatment" 4 patients were allocated with incorrect treatment and received AMG479 instead of Placebo.The total number of patients treated remains the same.	2.3% 2/88 • Number of events 2 • The monitoring period for AEs started from signature of the ICF and continued up to 30 days after last dose. For participant flow module it is based on Intent To Treat so the patients are counted according to their "randomization group".For "participants at risk" the patients are grouped by the "actual treatment" 4 patients were allocated with incorrect treatment and received AMG479 instead of Placebo.The total number of patients treated remains the same.
Psychiatric disorders Depression	7.8% 6/77 • Number of events 6 • The monitoring period for AEs started from signature of the ICF and continued up to 30 days after last dose. For participant flow module it is based on Intent To Treat so the patients are counted according to their "randomization group".For "participants at risk" the patients are grouped by the "actual treatment" 4 patients were allocated with incorrect treatment and received AMG479 instead of Placebo.The total number of patients treated remains the same.	2.3% 2/88 • Number of events 2 • The monitoring period for AEs started from signature of the ICF and continued up to 30 days after last dose. For participant flow module it is based on Intent To Treat so the patients are counted according to their "randomization group".For "participants at risk" the patients are grouped by the "actual treatment" 4 patients were allocated with incorrect treatment and received AMG479 instead of Placebo.The total number of patients treated remains the same.
Psychiatric disorders Insomnia	7.8% 6/77 • Number of events 6 • The monitoring period for AEs started from signature of the ICF and continued up to 30 days after last dose. For participant flow module it is based on Intent To Treat so the patients are counted according to their "randomization group".For "participants at risk" the patients are grouped by the "actual treatment" 4 patients were allocated with incorrect treatment and received AMG479 instead of Placebo.The total number of patients treated remains the same.	8.0% 7/88 • Number of events 7 • The monitoring period for AEs started from signature of the ICF and continued up to 30 days after last dose. For participant flow module it is based on Intent To Treat so the patients are counted according to their "randomization group".For "participants at risk" the patients are grouped by the "actual treatment" 4 patients were allocated with incorrect treatment and received AMG479 instead of Placebo.The total number of patients treated remains the same.
Respiratory, thoracic and mediastinal disorders Cough	9.1% 7/77 • Number of events 7 • The monitoring period for AEs started from signature of the ICF and continued up to 30 days after last dose. For participant flow module it is based on Intent To Treat so the patients are counted according to their "randomization group".For "participants at risk" the patients are grouped by the "actual treatment" 4 patients were allocated with incorrect treatment and received AMG479 instead of Placebo.The total number of patients treated remains the same.	10.2% 9/88 • Number of events 9 • The monitoring period for AEs started from signature of the ICF and continued up to 30 days after last dose. For participant flow module it is based on Intent To Treat so the patients are counted according to their "randomization group".For "participants at risk" the patients are grouped by the "actual treatment" 4 patients were allocated with incorrect treatment and received AMG479 instead of Placebo.The total number of patients treated remains the same.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	6.5% 5/77 • Number of events 5 • The monitoring period for AEs started from signature of the ICF and continued up to 30 days after last dose. For participant flow module it is based on Intent To Treat so the patients are counted according to their "randomization group".For "participants at risk" the patients are grouped by the "actual treatment" 4 patients were allocated with incorrect treatment and received AMG479 instead of Placebo.The total number of patients treated remains the same.	4.5% 4/88 • Number of events 4 • The monitoring period for AEs started from signature of the ICF and continued up to 30 days after last dose. For participant flow module it is based on Intent To Treat so the patients are counted according to their "randomization group".For "participants at risk" the patients are grouped by the "actual treatment" 4 patients were allocated with incorrect treatment and received AMG479 instead of Placebo.The total number of patients treated remains the same.
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	5.2% 4/77 • Number of events 4 • The monitoring period for AEs started from signature of the ICF and continued up to 30 days after last dose. For participant flow module it is based on Intent To Treat so the patients are counted according to their "randomization group".For "participants at risk" the patients are grouped by the "actual treatment" 4 patients were allocated with incorrect treatment and received AMG479 instead of Placebo.The total number of patients treated remains the same.	3.4% 3/88 • Number of events 3 • The monitoring period for AEs started from signature of the ICF and continued up to 30 days after last dose. For participant flow module it is based on Intent To Treat so the patients are counted according to their "randomization group".For "participants at risk" the patients are grouped by the "actual treatment" 4 patients were allocated with incorrect treatment and received AMG479 instead of Placebo.The total number of patients treated remains the same.
Skin and subcutaneous tissue disorders Acne	1.3% 1/77 • Number of events 1 • The monitoring period for AEs started from signature of the ICF and continued up to 30 days after last dose. For participant flow module it is based on Intent To Treat so the patients are counted according to their "randomization group".For "participants at risk" the patients are grouped by the "actual treatment" 4 patients were allocated with incorrect treatment and received AMG479 instead of Placebo.The total number of patients treated remains the same.	5.7% 5/88 • Number of events 6 • The monitoring period for AEs started from signature of the ICF and continued up to 30 days after last dose. For participant flow module it is based on Intent To Treat so the patients are counted according to their "randomization group".For "participants at risk" the patients are grouped by the "actual treatment" 4 patients were allocated with incorrect treatment and received AMG479 instead of Placebo.The total number of patients treated remains the same.
Skin and subcutaneous tissue disorders Alopecia	88.3% 68/77 • Number of events 68 • The monitoring period for AEs started from signature of the ICF and continued up to 30 days after last dose. For participant flow module it is based on Intent To Treat so the patients are counted according to their "randomization group".For "participants at risk" the patients are grouped by the "actual treatment" 4 patients were allocated with incorrect treatment and received AMG479 instead of Placebo.The total number of patients treated remains the same.	75.0% 66/88 • Number of events 66 • The monitoring period for AEs started from signature of the ICF and continued up to 30 days after last dose. For participant flow module it is based on Intent To Treat so the patients are counted according to their "randomization group".For "participants at risk" the patients are grouped by the "actual treatment" 4 patients were allocated with incorrect treatment and received AMG479 instead of Placebo.The total number of patients treated remains the same.
Skin and subcutaneous tissue disorders Dry skin	3.9% 3/77 • Number of events 3 • The monitoring period for AEs started from signature of the ICF and continued up to 30 days after last dose. For participant flow module it is based on Intent To Treat so the patients are counted according to their "randomization group".For "participants at risk" the patients are grouped by the "actual treatment" 4 patients were allocated with incorrect treatment and received AMG479 instead of Placebo.The total number of patients treated remains the same.	5.7% 5/88 • Number of events 5 • The monitoring period for AEs started from signature of the ICF and continued up to 30 days after last dose. For participant flow module it is based on Intent To Treat so the patients are counted according to their "randomization group".For "participants at risk" the patients are grouped by the "actual treatment" 4 patients were allocated with incorrect treatment and received AMG479 instead of Placebo.The total number of patients treated remains the same.
Skin and subcutaneous tissue disorders Nail disorder	2.6% 2/77 • Number of events 2 • The monitoring period for AEs started from signature of the ICF and continued up to 30 days after last dose. For participant flow module it is based on Intent To Treat so the patients are counted according to their "randomization group".For "participants at risk" the patients are grouped by the "actual treatment" 4 patients were allocated with incorrect treatment and received AMG479 instead of Placebo.The total number of patients treated remains the same.	9.1% 8/88 • Number of events 8 • The monitoring period for AEs started from signature of the ICF and continued up to 30 days after last dose. For participant flow module it is based on Intent To Treat so the patients are counted according to their "randomization group".For "participants at risk" the patients are grouped by the "actual treatment" 4 patients were allocated with incorrect treatment and received AMG479 instead of Placebo.The total number of patients treated remains the same.
Skin and subcutaneous tissue disorders Pruritus	14.3% 11/77 • Number of events 15 • The monitoring period for AEs started from signature of the ICF and continued up to 30 days after last dose. For participant flow module it is based on Intent To Treat so the patients are counted according to their "randomization group".For "participants at risk" the patients are grouped by the "actual treatment" 4 patients were allocated with incorrect treatment and received AMG479 instead of Placebo.The total number of patients treated remains the same.	12.5% 11/88 • Number of events 12 • The monitoring period for AEs started from signature of the ICF and continued up to 30 days after last dose. For participant flow module it is based on Intent To Treat so the patients are counted according to their "randomization group".For "participants at risk" the patients are grouped by the "actual treatment" 4 patients were allocated with incorrect treatment and received AMG479 instead of Placebo.The total number of patients treated remains the same.