Trial Outcomes & Findings for Carboplatin And Paclitaxel With Or Without CP-751, 871 (An IGF-1R Inhibitor) For Advanced NSCLC Of Squamous, Large Cell And Adenosquamous Carcinoma Histology (NCT NCT00596830)

Last Updated: 2014-01-13

Results Overview

Overall survival was the duration from randomization to death. For participants who are alive, overall survival was censored at the last contact.

Recruitment status

TERMINATED

Study phase

PHASE3

Target enrollment

681 participants

Primary outcome timeframe

Baseline until death, assessed monthly after end of treatment, up to 30 months

Results posted on

2014-01-13

Participant Flow

Participant milestones

Participant milestones
Measure	Figitumumab + Paclitaxel and Carboplatin Figitumumab (figi, \[CP-751, 871\]) was given in combination with paclitaxel (200 milligram/square metre \[mg/m\^2\]) and carboplatin (area under the concentration-time curve \[AUC\]=6) administered in 3-week cycles. Figi 20 milligram/kilogram (mg/kg) was administered intravenously (IV) on Day 1 of a 3-week cycle for up to 6 cycles, followed by single agent figi maintenance in every 3-week cycles after completion or discontinuation of chemotherapy for reasons other than disease progression.	Paclitaxel and Carboplatin (Chemo) Standard platinum-based doublet chemotherapy (chemo) consisting of paclitaxel (200 milligram/square metre \[mg/m\^2\]) and carboplatin (area under the concentration-time curve \[AUC\]=6) was administered via IV on Day 1 of a 3-week cycle. Chemo treatment continued for a maximum of 6 cycles.
Overall Study STARTED	342	339
Overall Study Treated	339	332
Overall Study COMPLETED	0	0
Overall Study NOT COMPLETED	342	339

Reasons for withdrawal

Reasons for withdrawal
Measure	Figitumumab + Paclitaxel and Carboplatin Figitumumab (figi, \[CP-751, 871\]) was given in combination with paclitaxel (200 milligram/square metre \[mg/m\^2\]) and carboplatin (area under the concentration-time curve \[AUC\]=6) administered in 3-week cycles. Figi 20 milligram/kilogram (mg/kg) was administered intravenously (IV) on Day 1 of a 3-week cycle for up to 6 cycles, followed by single agent figi maintenance in every 3-week cycles after completion or discontinuation of chemotherapy for reasons other than disease progression.	Paclitaxel and Carboplatin (Chemo) Standard platinum-based doublet chemotherapy (chemo) consisting of paclitaxel (200 milligram/square metre \[mg/m\^2\]) and carboplatin (area under the concentration-time curve \[AUC\]=6) was administered via IV on Day 1 of a 3-week cycle. Chemo treatment continued for a maximum of 6 cycles.
Overall Study Death	258	247
Overall Study Lost to Follow-up	7	11
Overall Study Withdrawal by Subject	22	12
Overall Study Study terminated by sponsor	51	62
Overall Study Follow-up was discontinued	1	0
Overall Study Randomized but not treated	3	7

Baseline Characteristics

Carboplatin And Paclitaxel With Or Without CP-751, 871 (An IGF-1R Inhibitor) For Advanced NSCLC Of Squamous, Large Cell And Adenosquamous Carcinoma Histology

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Figitumumab + Paclitaxel and Carboplatin n=342 Participants Figitumumab (figi, \[CP-751, 871\]) was given in combination with paclitaxel (200 milligram/square metre \[mg/m\^2\]) and carboplatin (area under the concentration-time curve \[AUC\]=6) administered in 3-week cycles. Figi 20 milligram/kilogram (mg/kg) was administered intravenously (IV) on Day 1 of a 3-week cycle for up to 6 cycles, followed by single agent figi maintenance in every 3-week cycles after completion or discontinuation of chemotherapy for reasons other than disease progression.	Paclitaxel and Carboplatin (Chemo) n=339 Participants Standard platinum-based doublet chemotherapy (chemo) consisting of paclitaxel (200 milligram/square metre \[mg/m\^2\]) and carboplatin (area under the concentration-time curve \[AUC\]=6) was administered via IV on Day 1 of a 3-week cycle. Chemo treatment continued for a maximum of 6 cycles.	Total n=681 Participants Total of all reporting groups
Age, Continuous	61.8 years STANDARD_DEVIATION 9.0 • n=5 Participants	61.8 years STANDARD_DEVIATION 9.1 • n=7 Participants	61.8 years STANDARD_DEVIATION 9.0 • n=5 Participants
Sex: Female, Male Female	81 Participants n=5 Participants	79 Participants n=7 Participants	160 Participants n=5 Participants
Sex: Female, Male Male	261 Participants n=5 Participants	260 Participants n=7 Participants	521 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline until death, assessed monthly after end of treatment, up to 30 months

Population: All randomized participants where participants were classified according to the randomized treatment regardless of what treatment, if any, was received.

Overall survival was the duration from randomization to death. For participants who are alive, overall survival was censored at the last contact.

Outcome measures

Outcome measures
Measure	Figitumumab + Paclitaxel and Carboplatin n=342 Participants Figitumumab (figi, \[CP-751, 871\]) was given in combination with paclitaxel (200 milligram/square metre \[mg/m\^2\]) and carboplatin (area under the concentration-time curve \[AUC\]=6) administered in 3-week cycles. Figi 20 milligram/kilogram (mg/kg) was administered intravenously (IV) on Day 1 of a 3-week cycle for up to 6 cycles, followed by single agent figi maintenance in every 3-week cycles after completion or discontinuation of chemotherapy for reasons other than disease progression.	Paclitaxel and Carboplatin (Chemo) n=339 Participants Standard platinum-based doublet chemotherapy (chemo) consisting of paclitaxel (200 milligram/square metre \[mg/m\^2\]) and carboplatin (area under the concentration-time curve \[AUC\]=6) was administered via IV on Day 1 of a 3-week cycle. Chemo treatment continued for a maximum of 6 cycles.
Overall Survival (OS)	8.6 months Interval 7.4 to 9.3	9.8 months Interval 8.6 to 10.9

SECONDARY outcome

Timeframe: At baseline, every 6 weeks until radiological disease progression or the participant begins a subsequent anticancer therapy, up to 22.7 months.

Population: All randomized participants where participants were classified according to the randomized treatment regardless of what treatment, if any, was received.

PFS was defined as the time from randomization to first progression or death due to any cause, whichever came first. Participants last known to be alive and progression-free, with baseline and \>=1 on-study assessment, were censored at last disease assessment verifying lack of progression. Progression was determined by the investigator per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.0 (20% increase in the sum of target lesions' longest diameter over nadir, unequivocal progression of non-target disease, or appearance of new lesions).

Outcome measures

Outcome measures
Measure	Figitumumab + Paclitaxel and Carboplatin n=342 Participants Figitumumab (figi, \[CP-751, 871\]) was given in combination with paclitaxel (200 milligram/square metre \[mg/m\^2\]) and carboplatin (area under the concentration-time curve \[AUC\]=6) administered in 3-week cycles. Figi 20 milligram/kilogram (mg/kg) was administered intravenously (IV) on Day 1 of a 3-week cycle for up to 6 cycles, followed by single agent figi maintenance in every 3-week cycles after completion or discontinuation of chemotherapy for reasons other than disease progression.	Paclitaxel and Carboplatin (Chemo) n=339 Participants Standard platinum-based doublet chemotherapy (chemo) consisting of paclitaxel (200 milligram/square metre \[mg/m\^2\]) and carboplatin (area under the concentration-time curve \[AUC\]=6) was administered via IV on Day 1 of a 3-week cycle. Chemo treatment continued for a maximum of 6 cycles.
Progression-Free Survival (PFS)	4.7 months Interval 4.2 to 5.4	4.6 months Interval 4.2 to 5.4

SECONDARY outcome

Timeframe: At baseline, every 6 weeks until radiological disease progression has been documented or the participant begins a subsequent anticancer therapy, up to 22.7 months

Population: All randomized participants where participants were classified according to the randomized treatment regardless of what treatment, if any, was received.

Percentage of participants with OR based on assessment of confirmed complete response (CR) or confirmed partial response(PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). CR defined as complete disappearance of all target lesions and non-target disease. No new lesons. PR defined as ≥30% decrease under baseline of the sum of diameters of all target lesions. No unequivocal progression of non-target disease. No new lesions.

Outcome measures

Outcome measures
Measure	Figitumumab + Paclitaxel and Carboplatin n=342 Participants Figitumumab (figi, \[CP-751, 871\]) was given in combination with paclitaxel (200 milligram/square metre \[mg/m\^2\]) and carboplatin (area under the concentration-time curve \[AUC\]=6) administered in 3-week cycles. Figi 20 milligram/kilogram (mg/kg) was administered intravenously (IV) on Day 1 of a 3-week cycle for up to 6 cycles, followed by single agent figi maintenance in every 3-week cycles after completion or discontinuation of chemotherapy for reasons other than disease progression.	Paclitaxel and Carboplatin (Chemo) n=339 Participants Standard platinum-based doublet chemotherapy (chemo) consisting of paclitaxel (200 milligram/square metre \[mg/m\^2\]) and carboplatin (area under the concentration-time curve \[AUC\]=6) was administered via IV on Day 1 of a 3-week cycle. Chemo treatment continued for a maximum of 6 cycles.
Percentage of Participants With Objective Response (OR)	33.0 percentage of participants Interval 28.1 to 38.3	34.5 percentage of participants Interval 29.5 to 39.8

SECONDARY outcome

Timeframe: Day 1 of every cycle (3-week cycle), every 3 weeks during maintenance phase and at the End of Treatment Visit, assessed up to 37.4 months

Population: Due to futility, the study was terminated early; therefore these data were not analyzed.

EORTC QLQ-C30: included functional scales (physical, role, cognitive, emotional, and social), global health status, symptom scales (fatigue, pain, nausea/vomiting) and single items (dyspnoea, appetite loss, insomnia, constipation/diarrhea and financial difficulties). Most questions used 4 point scale (1 'Not at all' to 4 'Very much'; 2 questions used 7-point scale (1 'very poor' to 7 'Excellent'). Scores averaged, transformed to 0-100 scale; higher score=better level of functioning or greater degree of symptoms.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Day 1 of every cycle (3-week cycle), every 3 weeks during maintenance phase and at the End of Treatment Visit, assessed up to 37.4 months

Population: Due to futility, the study was terminated early; therefore these data were not analyzed.

QLQ-LC13 consisted of 13 questions relating to disease symptoms specific to lung cancer and treatment side effects typical of treatment with chemotherapy and radiotherapy. The 13 questions comprised 1 multi-item scale for dyspnea and 10 single-item symptoms and side effects (coughing, hemoptysis, sore mouth, dysphagia, peripheral neuropathy, alopecia, chest pain, arm pain, other pain, and medicine for pain). Recall period: past week; response range: not at all to very much. Scale score range: 0 to 100. Higher symptom score = greater degree of symptoms.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Day 1 of every cycle (3-weeks cycle), every 3 weeks during maintenance phase and at the End of Treatment Visit, assessed up to 37.4 months

Population: Due to futility, the study was terminated early; therefore EQ-5D data were not analyzed.

EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state ("confined to bed"). Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range of -0.594 to 1; higher score indicates a better health state.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Cycle 1, Day 1 (predose and 1 hour after end of infusion); Day 1 of Cycles 2, 4, 6 (predose); Cycle 5 Day 1 (predose, 1 hour after end of infusion); 28 days and 150 days after the last figi dose

Population: This study was terminated early due to futility. As such, Cmax was not summarized.

Outcome measures

Outcome data not reported

SECONDARY outcome

Population: This study was terminated early due to futility. As such, Cmin was not summarized.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Cycles 1, 2, and 4 (predose); 28 days and 150 days after the last figi dose

Population: All participants who received figitumumab (CP-751,871).

ADAs are immunogenicity indicators to figitumumab. Participants reporting positive for ADAs are indicated by an endpoint titer of no less than 6.64.

Outcome measures

Outcome measures
Measure	Figitumumab + Paclitaxel and Carboplatin n=332 Participants Figitumumab (figi, \[CP-751, 871\]) was given in combination with paclitaxel (200 milligram/square metre \[mg/m\^2\]) and carboplatin (area under the concentration-time curve \[AUC\]=6) administered in 3-week cycles. Figi 20 milligram/kilogram (mg/kg) was administered intravenously (IV) on Day 1 of a 3-week cycle for up to 6 cycles, followed by single agent figi maintenance in every 3-week cycles after completion or discontinuation of chemotherapy for reasons other than disease progression.	Paclitaxel and Carboplatin (Chemo) n=32 Participants Standard platinum-based doublet chemotherapy (chemo) consisting of paclitaxel (200 milligram/square metre \[mg/m\^2\]) and carboplatin (area under the concentration-time curve \[AUC\]=6) was administered via IV on Day 1 of a 3-week cycle. Chemo treatment continued for a maximum of 6 cycles.
Number of Participants With Total Anti-drug Antibodies (ADA)	2 participants	0 participants

SECONDARY outcome

Timeframe: Cycles 1 and 4 (predose) and at end of treatment

Population: This study was terminated early due to futility. As such, these data were not analyzed.

Outcome measures

Outcome data not reported

Adverse Events

Figitumumab + Paclitaxel and Carboplatin

Serious events: 223 serious events

Other events: 316 other events

Deaths: 0 deaths

Paclitaxel and Carboplatin (Chemo)

Serious events: 170 serious events

Other events: 303 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Additional Information

Pfizer ClinicalTrials.gov Call Center

Pfizer, Inc.

Phone: 1-800-718-1021

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
Publication restrictions are in place

Restriction type: OTHER

Serious adverse events
Measure	Figitumumab + Paclitaxel and Carboplatin n=338 participants at risk Figitumumab (figi, \[CP-751, 871\]) was given in combination with paclitaxel (200 milligram/square metre \[mg/m\^2\]) and carboplatin (area under the concentration-time curve \[AUC\]=6) administered in 3-week cycles. Figi 20 milligram/kilogram (mg/kg) was administered intravenously (IV) on Day 1 of a 3-week cycle for up to 6 cycles, followed by single agent figi maintenance in every 3-week cycles after completion or discontinuation of chemotherapy for reasons other than disease progression.	Paclitaxel and Carboplatin (Chemo) n=333 participants at risk Standard platinum-based doublet chemotherapy (chemo) consisting of paclitaxel (200 milligram/square metre \[mg/m\^2\]) and carboplatin (area under the concentration-time curve \[AUC\]=6) was administered via IV on Day 1 of a 3-week cycle. Chemo treatment continued for a maximum of 6 cycles.
Infections and infestations Candidiasis	0.30% 1/338 Distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another, or 1 subject may have experienced both kinds of events. The 1 participant who was randomized to receive figi and chemo but was treated only with chemo is included under the chemo group. Only treated participants are included.	0.00% 0/333 Distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another, or 1 subject may have experienced both kinds of events. The 1 participant who was randomized to receive figi and chemo but was treated only with chemo is included under the chemo group. Only treated participants are included.
Infections and infestations Cellulitis	0.30% 1/338 Distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another, or 1 subject may have experienced both kinds of events. The 1 participant who was randomized to receive figi and chemo but was treated only with chemo is included under the chemo group. Only treated participants are included.	0.00% 0/333 Distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another, or 1 subject may have experienced both kinds of events. The 1 participant who was randomized to receive figi and chemo but was treated only with chemo is included under the chemo group. Only treated participants are included.
Infections and infestations Diverticulitis	0.59% 2/338 Distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another, or 1 subject may have experienced both kinds of events. The 1 participant who was randomized to receive figi and chemo but was treated only with chemo is included under the chemo group. Only treated participants are included.	0.00% 0/333 Distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another, or 1 subject may have experienced both kinds of events. The 1 participant who was randomized to receive figi and chemo but was treated only with chemo is included under the chemo group. Only treated participants are included.
Blood and lymphatic system disorders Anaemia	0.59% 2/338 Distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another, or 1 subject may have experienced both kinds of events. The 1 participant who was randomized to receive figi and chemo but was treated only with chemo is included under the chemo group. Only treated participants are included.	2.7% 9/333 Distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another, or 1 subject may have experienced both kinds of events. The 1 participant who was randomized to receive figi and chemo but was treated only with chemo is included under the chemo group. Only treated participants are included.
Blood and lymphatic system disorders Bone marrow failure	0.30% 1/338 Distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another, or 1 subject may have experienced both kinds of events. The 1 participant who was randomized to receive figi and chemo but was treated only with chemo is included under the chemo group. Only treated participants are included.	0.00% 0/333 Distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another, or 1 subject may have experienced both kinds of events. The 1 participant who was randomized to receive figi and chemo but was treated only with chemo is included under the chemo group. Only treated participants are included.
Blood and lymphatic system disorders Febrile bone marrow aplasia	0.00% 0/338 Distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another, or 1 subject may have experienced both kinds of events. The 1 participant who was randomized to receive figi and chemo but was treated only with chemo is included under the chemo group. Only treated participants are included.	0.30% 1/333 Distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another, or 1 subject may have experienced both kinds of events. The 1 participant who was randomized to receive figi and chemo but was treated only with chemo is included under the chemo group. Only treated participants are included.
Blood and lymphatic system disorders Febrile neutropenia	1.5% 5/338 Distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another, or 1 subject may have experienced both kinds of events. The 1 participant who was randomized to receive figi and chemo but was treated only with chemo is included under the chemo group. Only treated participants are included.	3.3% 11/333 Distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another, or 1 subject may have experienced both kinds of events. The 1 participant who was randomized to receive figi and chemo but was treated only with chemo is included under the chemo group. Only treated participants are included.
Blood and lymphatic system disorders Granulocytopenia	0.30% 1/338 Distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another, or 1 subject may have experienced both kinds of events. The 1 participant who was randomized to receive figi and chemo but was treated only with chemo is included under the chemo group. Only treated participants are included.	0.60% 2/333 Distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another, or 1 subject may have experienced both kinds of events. The 1 participant who was randomized to receive figi and chemo but was treated only with chemo is included under the chemo group. Only treated participants are included.
Blood and lymphatic system disorders Leukopenia	0.30% 1/338 Distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another, or 1 subject may have experienced both kinds of events. The 1 participant who was randomized to receive figi and chemo but was treated only with chemo is included under the chemo group. Only treated participants are included.	0.30% 1/333 Distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another, or 1 subject may have experienced both kinds of events. The 1 participant who was randomized to receive figi and chemo but was treated only with chemo is included under the chemo group. Only treated participants are included.
Blood and lymphatic system disorders Neutropenia	1.5% 5/338 Distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another, or 1 subject may have experienced both kinds of events. The 1 participant who was randomized to receive figi and chemo but was treated only with chemo is included under the chemo group. Only treated participants are included.	0.30% 1/333 Distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another, or 1 subject may have experienced both kinds of events. The 1 participant who was randomized to receive figi and chemo but was treated only with chemo is included under the chemo group. Only treated participants are included.
Blood and lymphatic system disorders Pancytopenia	0.59% 2/338 Distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another, or 1 subject may have experienced both kinds of events. The 1 participant who was randomized to receive figi and chemo but was treated only with chemo is included under the chemo group. Only treated participants are included.	0.00% 0/333 Distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another, or 1 subject may have experienced both kinds of events. The 1 participant who was randomized to receive figi and chemo but was treated only with chemo is included under the chemo group. Only treated participants are included.
Blood and lymphatic system disorders Thrombocytopenia	0.59% 2/338 Distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another, or 1 subject may have experienced both kinds of events. The 1 participant who was randomized to receive figi and chemo but was treated only with chemo is included under the chemo group. Only treated participants are included.	1.5% 5/333 Distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another, or 1 subject may have experienced both kinds of events. The 1 participant who was randomized to receive figi and chemo but was treated only with chemo is included under the chemo group. Only treated participants are included.
Cardiac disorders Angina pectoris	0.30% 1/338 Distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another, or 1 subject may have experienced both kinds of events. The 1 participant who was randomized to receive figi and chemo but was treated only with chemo is included under the chemo group. Only treated participants are included.	0.30% 1/333 Distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another, or 1 subject may have experienced both kinds of events. The 1 participant who was randomized to receive figi and chemo but was treated only with chemo is included under the chemo group. Only treated participants are included.
Cardiac disorders Arrhythmia	0.30% 1/338 Distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another, or 1 subject may have experienced both kinds of events. The 1 participant who was randomized to receive figi and chemo but was treated only with chemo is included under the chemo group. Only treated participants are included.	0.00% 0/333 Distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another, or 1 subject may have experienced both kinds of events. The 1 participant who was randomized to receive figi and chemo but was treated only with chemo is included under the chemo group. Only treated participants are included.
Cardiac disorders Atrial fibrillation	0.30% 1/338 Distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another, or 1 subject may have experienced both kinds of events. The 1 participant who was randomized to receive figi and chemo but was treated only with chemo is included under the chemo group. Only treated participants are included.	0.30% 1/333 Distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another, or 1 subject may have experienced both kinds of events. The 1 participant who was randomized to receive figi and chemo but was treated only with chemo is included under the chemo group. Only treated participants are included.
Cardiac disorders Cardiac arrest	0.30% 1/338 Distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another, or 1 subject may have experienced both kinds of events. The 1 participant who was randomized to receive figi and chemo but was treated only with chemo is included under the chemo group. Only treated participants are included.	0.00% 0/333 Distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another, or 1 subject may have experienced both kinds of events. The 1 participant who was randomized to receive figi and chemo but was treated only with chemo is included under the chemo group. Only treated participants are included.
Cardiac disorders Cardiac failure	0.30% 1/338 Distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another, or 1 subject may have experienced both kinds of events. The 1 participant who was randomized to receive figi and chemo but was treated only with chemo is included under the chemo group. Only treated participants are included.	0.30% 1/333 Distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another, or 1 subject may have experienced both kinds of events. The 1 participant who was randomized to receive figi and chemo but was treated only with chemo is included under the chemo group. Only treated participants are included.
Cardiac disorders Cardiac failure congestive	0.00% 0/338 Distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another, or 1 subject may have experienced both kinds of events. The 1 participant who was randomized to receive figi and chemo but was treated only with chemo is included under the chemo group. Only treated participants are included.	0.30% 1/333 Distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another, or 1 subject may have experienced both kinds of events. The 1 participant who was randomized to receive figi and chemo but was treated only with chemo is included under the chemo group. Only treated participants are included.
Cardiac disorders Cardio-respiratory arrest	0.30% 1/338 Distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another, or 1 subject may have experienced both kinds of events. The 1 participant who was randomized to receive figi and chemo but was treated only with chemo is included under the chemo group. Only treated participants are included.	0.30% 1/333 Distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another, or 1 subject may have experienced both kinds of events. The 1 participant who was randomized to receive figi and chemo but was treated only with chemo is included under the chemo group. Only treated participants are included.
Cardiac disorders Cardiopulmonary failure	0.89% 3/338 Distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another, or 1 subject may have experienced both kinds of events. The 1 participant who was randomized to receive figi and chemo but was treated only with chemo is included under the chemo group. Only treated participants are included.	0.30% 1/333 Distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another, or 1 subject may have experienced both kinds of events. The 1 participant who was randomized to receive figi and chemo but was treated only with chemo is included under the chemo group. Only treated participants are included.
Cardiac disorders Cardiotoxicity	0.30% 1/338 Distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another, or 1 subject may have experienced both kinds of events. The 1 participant who was randomized to receive figi and chemo but was treated only with chemo is included under the chemo group. Only treated participants are included.	0.00% 0/333 Distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another, or 1 subject may have experienced both kinds of events. The 1 participant who was randomized to receive figi and chemo but was treated only with chemo is included under the chemo group. Only treated participants are included.
Cardiac disorders Cardiovascular disorder	0.59% 2/338 Distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another, or 1 subject may have experienced both kinds of events. The 1 participant who was randomized to receive figi and chemo but was treated only with chemo is included under the chemo group. Only treated participants are included.	0.00% 0/333 Distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another, or 1 subject may have experienced both kinds of events. The 1 participant who was randomized to receive figi and chemo but was treated only with chemo is included under the chemo group. Only treated participants are included.
Cardiac disorders Myocardial infarction	0.59% 2/338 Distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another, or 1 subject may have experienced both kinds of events. The 1 participant who was randomized to receive figi and chemo but was treated only with chemo is included under the chemo group. Only treated participants are included.	0.60% 2/333 Distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another, or 1 subject may have experienced both kinds of events. The 1 participant who was randomized to receive figi and chemo but was treated only with chemo is included under the chemo group. Only treated participants are included.
Cardiac disorders Myocardial ischaemia	0.59% 2/338 Distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another, or 1 subject may have experienced both kinds of events. The 1 participant who was randomized to receive figi and chemo but was treated only with chemo is included under the chemo group. Only treated participants are included.	0.00% 0/333 Distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another, or 1 subject may have experienced both kinds of events. The 1 participant who was randomized to receive figi and chemo but was treated only with chemo is included under the chemo group. Only treated participants are included.
Cardiac disorders Tachyarrhythmia	0.30% 1/338 Distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another, or 1 subject may have experienced both kinds of events. The 1 participant who was randomized to receive figi and chemo but was treated only with chemo is included under the chemo group. Only treated participants are included.	0.00% 0/333 Distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another, or 1 subject may have experienced both kinds of events. The 1 participant who was randomized to receive figi and chemo but was treated only with chemo is included under the chemo group. Only treated participants are included.
Ear and labyrinth disorders Vertigo	0.30% 1/338 Distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another, or 1 subject may have experienced both kinds of events. The 1 participant who was randomized to receive figi and chemo but was treated only with chemo is included under the chemo group. Only treated participants are included.	0.00% 0/333 Distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another, or 1 subject may have experienced both kinds of events. The 1 participant who was randomized to receive figi and chemo but was treated only with chemo is included under the chemo group. Only treated participants are included.
Endocrine disorders Adrenal insufficiency	0.30% 1/338 Distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another, or 1 subject may have experienced both kinds of events. The 1 participant who was randomized to receive figi and chemo but was treated only with chemo is included under the chemo group. Only treated participants are included.	0.00% 0/333 Distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another, or 1 subject may have experienced both kinds of events. The 1 participant who was randomized to receive figi and chemo but was treated only with chemo is included under the chemo group. Only treated participants are included.
Endocrine disorders Inappropriate antidiuretic hormone secretion	0.30% 1/338 Distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another, or 1 subject may have experienced both kinds of events. The 1 participant who was randomized to receive figi and chemo but was treated only with chemo is included under the chemo group. Only treated participants are included.	0.00% 0/333 Distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another, or 1 subject may have experienced both kinds of events. The 1 participant who was randomized to receive figi and chemo but was treated only with chemo is included under the chemo group. Only treated participants are included.
Gastrointestinal disorders Abdominal pain	0.30% 1/338 Distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another, or 1 subject may have experienced both kinds of events. The 1 participant who was randomized to receive figi and chemo but was treated only with chemo is included under the chemo group. Only treated participants are included.	0.00% 0/333 Distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another, or 1 subject may have experienced both kinds of events. The 1 participant who was randomized to receive figi and chemo but was treated only with chemo is included under the chemo group. Only treated participants are included.
Gastrointestinal disorders Abdominal pain upper	0.30% 1/338 Distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another, or 1 subject may have experienced both kinds of events. The 1 participant who was randomized to receive figi and chemo but was treated only with chemo is included under the chemo group. Only treated participants are included.	0.00% 0/333 Distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another, or 1 subject may have experienced both kinds of events. The 1 participant who was randomized to receive figi and chemo but was treated only with chemo is included under the chemo group. Only treated participants are included.
Gastrointestinal disorders Anal fistula	0.30% 1/338 Distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another, or 1 subject may have experienced both kinds of events. The 1 participant who was randomized to receive figi and chemo but was treated only with chemo is included under the chemo group. Only treated participants are included.	0.00% 0/333 Distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another, or 1 subject may have experienced both kinds of events. The 1 participant who was randomized to receive figi and chemo but was treated only with chemo is included under the chemo group. Only treated participants are included.
Gastrointestinal disorders Diarrhoea	2.7% 9/338 Distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another, or 1 subject may have experienced both kinds of events. The 1 participant who was randomized to receive figi and chemo but was treated only with chemo is included under the chemo group. Only treated participants are included.	0.00% 0/333 Distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another, or 1 subject may have experienced both kinds of events. The 1 participant who was randomized to receive figi and chemo but was treated only with chemo is included under the chemo group. Only treated participants are included.
Gastrointestinal disorders Duodenal ulcer	0.00% 0/338 Distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another, or 1 subject may have experienced both kinds of events. The 1 participant who was randomized to receive figi and chemo but was treated only with chemo is included under the chemo group. Only treated participants are included.	0.30% 1/333 Distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another, or 1 subject may have experienced both kinds of events. The 1 participant who was randomized to receive figi and chemo but was treated only with chemo is included under the chemo group. Only treated participants are included.
Gastrointestinal disorders Dysphagia	0.30% 1/338 Distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another, or 1 subject may have experienced both kinds of events. The 1 participant who was randomized to receive figi and chemo but was treated only with chemo is included under the chemo group. Only treated participants are included.	0.30% 1/333 Distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another, or 1 subject may have experienced both kinds of events. The 1 participant who was randomized to receive figi and chemo but was treated only with chemo is included under the chemo group. Only treated participants are included.
Gastrointestinal disorders Gastric disorder	0.30% 1/338 Distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another, or 1 subject may have experienced both kinds of events. The 1 participant who was randomized to receive figi and chemo but was treated only with chemo is included under the chemo group. Only treated participants are included.	0.00% 0/333 Distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another, or 1 subject may have experienced both kinds of events. The 1 participant who was randomized to receive figi and chemo but was treated only with chemo is included under the chemo group. Only treated participants are included.
Gastrointestinal disorders Gastric perforation	0.30% 1/338 Distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another, or 1 subject may have experienced both kinds of events. The 1 participant who was randomized to receive figi and chemo but was treated only with chemo is included under the chemo group. Only treated participants are included.	0.00% 0/333 Distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another, or 1 subject may have experienced both kinds of events. The 1 participant who was randomized to receive figi and chemo but was treated only with chemo is included under the chemo group. Only treated participants are included.
Gastrointestinal disorders Gastrointestinal haemorrhage	0.59% 2/338 Distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another, or 1 subject may have experienced both kinds of events. The 1 participant who was randomized to receive figi and chemo but was treated only with chemo is included under the chemo group. Only treated participants are included.	0.30% 1/333 Distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another, or 1 subject may have experienced both kinds of events. The 1 participant who was randomized to receive figi and chemo but was treated only with chemo is included under the chemo group. Only treated participants are included.
Gastrointestinal disorders Glossitis	0.30% 1/338 Distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another, or 1 subject may have experienced both kinds of events. The 1 participant who was randomized to receive figi and chemo but was treated only with chemo is included under the chemo group. Only treated participants are included.	0.00% 0/333 Distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another, or 1 subject may have experienced both kinds of events. The 1 participant who was randomized to receive figi and chemo but was treated only with chemo is included under the chemo group. Only treated participants are included.
Gastrointestinal disorders Haematemesis	0.00% 0/338 Distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another, or 1 subject may have experienced both kinds of events. The 1 participant who was randomized to receive figi and chemo but was treated only with chemo is included under the chemo group. Only treated participants are included.	0.30% 1/333 Distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another, or 1 subject may have experienced both kinds of events. The 1 participant who was randomized to receive figi and chemo but was treated only with chemo is included under the chemo group. Only treated participants are included.
Gastrointestinal disorders Haemorrhoids	0.30% 1/338 Distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another, or 1 subject may have experienced both kinds of events. The 1 participant who was randomized to receive figi and chemo but was treated only with chemo is included under the chemo group. Only treated participants are included.	0.00% 0/333 Distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another, or 1 subject may have experienced both kinds of events. The 1 participant who was randomized to receive figi and chemo but was treated only with chemo is included under the chemo group. Only treated participants are included.

Other adverse events
Measure	Figitumumab + Paclitaxel and Carboplatin n=338 participants at risk Figitumumab (figi, \[CP-751, 871\]) was given in combination with paclitaxel (200 milligram/square metre \[mg/m\^2\]) and carboplatin (area under the concentration-time curve \[AUC\]=6) administered in 3-week cycles. Figi 20 milligram/kilogram (mg/kg) was administered intravenously (IV) on Day 1 of a 3-week cycle for up to 6 cycles, followed by single agent figi maintenance in every 3-week cycles after completion or discontinuation of chemotherapy for reasons other than disease progression.	Paclitaxel and Carboplatin (Chemo) n=333 participants at risk Standard platinum-based doublet chemotherapy (chemo) consisting of paclitaxel (200 milligram/square metre \[mg/m\^2\]) and carboplatin (area under the concentration-time curve \[AUC\]=6) was administered via IV on Day 1 of a 3-week cycle. Chemo treatment continued for a maximum of 6 cycles.
Blood and lymphatic system disorders Anaemia	27.5% 93/338 Distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another, or 1 subject may have experienced both kinds of events. The 1 participant who was randomized to receive figi and chemo but was treated only with chemo is included under the chemo group. Only treated participants are included.	25.5% 85/333 Distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another, or 1 subject may have experienced both kinds of events. The 1 participant who was randomized to receive figi and chemo but was treated only with chemo is included under the chemo group. Only treated participants are included.
Blood and lymphatic system disorders Leukopenia	5.3% 18/338 Distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another, or 1 subject may have experienced both kinds of events. The 1 participant who was randomized to receive figi and chemo but was treated only with chemo is included under the chemo group. Only treated participants are included.	9.9% 33/333 Distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another, or 1 subject may have experienced both kinds of events. The 1 participant who was randomized to receive figi and chemo but was treated only with chemo is included under the chemo group. Only treated participants are included.
Blood and lymphatic system disorders Neutropenia	21.9% 74/338 Distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another, or 1 subject may have experienced both kinds of events. The 1 participant who was randomized to receive figi and chemo but was treated only with chemo is included under the chemo group. Only treated participants are included.	23.4% 78/333 Distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another, or 1 subject may have experienced both kinds of events. The 1 participant who was randomized to receive figi and chemo but was treated only with chemo is included under the chemo group. Only treated participants are included.
Blood and lymphatic system disorders Thrombocytopenia	17.8% 60/338 Distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another, or 1 subject may have experienced both kinds of events. The 1 participant who was randomized to receive figi and chemo but was treated only with chemo is included under the chemo group. Only treated participants are included.	14.7% 49/333 Distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another, or 1 subject may have experienced both kinds of events. The 1 participant who was randomized to receive figi and chemo but was treated only with chemo is included under the chemo group. Only treated participants are included.
Gastrointestinal disorders Constipation	17.8% 60/338 Distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another, or 1 subject may have experienced both kinds of events. The 1 participant who was randomized to receive figi and chemo but was treated only with chemo is included under the chemo group. Only treated participants are included.	18.3% 61/333 Distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another, or 1 subject may have experienced both kinds of events. The 1 participant who was randomized to receive figi and chemo but was treated only with chemo is included under the chemo group. Only treated participants are included.
Gastrointestinal disorders Diarrhoea	28.1% 95/338 Distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another, or 1 subject may have experienced both kinds of events. The 1 participant who was randomized to receive figi and chemo but was treated only with chemo is included under the chemo group. Only treated participants are included.	13.5% 45/333 Distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another, or 1 subject may have experienced both kinds of events. The 1 participant who was randomized to receive figi and chemo but was treated only with chemo is included under the chemo group. Only treated participants are included.
Gastrointestinal disorders Dysphagia	5.3% 18/338 Distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another, or 1 subject may have experienced both kinds of events. The 1 participant who was randomized to receive figi and chemo but was treated only with chemo is included under the chemo group. Only treated participants are included.	2.7% 9/333 Distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another, or 1 subject may have experienced both kinds of events. The 1 participant who was randomized to receive figi and chemo but was treated only with chemo is included under the chemo group. Only treated participants are included.
Gastrointestinal disorders Nausea	39.1% 132/338 Distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another, or 1 subject may have experienced both kinds of events. The 1 participant who was randomized to receive figi and chemo but was treated only with chemo is included under the chemo group. Only treated participants are included.	30.3% 101/333 Distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another, or 1 subject may have experienced both kinds of events. The 1 participant who was randomized to receive figi and chemo but was treated only with chemo is included under the chemo group. Only treated participants are included.
Gastrointestinal disorders Stomatitis	8.9% 30/338 Distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another, or 1 subject may have experienced both kinds of events. The 1 participant who was randomized to receive figi and chemo but was treated only with chemo is included under the chemo group. Only treated participants are included.	3.0% 10/333 Distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another, or 1 subject may have experienced both kinds of events. The 1 participant who was randomized to receive figi and chemo but was treated only with chemo is included under the chemo group. Only treated participants are included.
Gastrointestinal disorders Vomiting	24.3% 82/338 Distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another, or 1 subject may have experienced both kinds of events. The 1 participant who was randomized to receive figi and chemo but was treated only with chemo is included under the chemo group. Only treated participants are included.	13.8% 46/333 Distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another, or 1 subject may have experienced both kinds of events. The 1 participant who was randomized to receive figi and chemo but was treated only with chemo is included under the chemo group. Only treated participants are included.
General disorders Asthenia	21.0% 71/338 Distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another, or 1 subject may have experienced both kinds of events. The 1 participant who was randomized to receive figi and chemo but was treated only with chemo is included under the chemo group. Only treated participants are included.	17.7% 59/333 Distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another, or 1 subject may have experienced both kinds of events. The 1 participant who was randomized to receive figi and chemo but was treated only with chemo is included under the chemo group. Only treated participants are included.
General disorders Chest pain	13.3% 45/338 Distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another, or 1 subject may have experienced both kinds of events. The 1 participant who was randomized to receive figi and chemo but was treated only with chemo is included under the chemo group. Only treated participants are included.	10.2% 34/333 Distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another, or 1 subject may have experienced both kinds of events. The 1 participant who was randomized to receive figi and chemo but was treated only with chemo is included under the chemo group. Only treated participants are included.
General disorders Fatigue	33.1% 112/338 Distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another, or 1 subject may have experienced both kinds of events. The 1 participant who was randomized to receive figi and chemo but was treated only with chemo is included under the chemo group. Only treated participants are included.	25.5% 85/333 Distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another, or 1 subject may have experienced both kinds of events. The 1 participant who was randomized to receive figi and chemo but was treated only with chemo is included under the chemo group. Only treated participants are included.
General disorders Mucosal inflammation	8.0% 27/338 Distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another, or 1 subject may have experienced both kinds of events. The 1 participant who was randomized to receive figi and chemo but was treated only with chemo is included under the chemo group. Only treated participants are included.	2.7% 9/333 Distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another, or 1 subject may have experienced both kinds of events. The 1 participant who was randomized to receive figi and chemo but was treated only with chemo is included under the chemo group. Only treated participants are included.
General disorders Oedema peripheral	3.0% 10/338 Distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another, or 1 subject may have experienced both kinds of events. The 1 participant who was randomized to receive figi and chemo but was treated only with chemo is included under the chemo group. Only treated participants are included.	7.2% 24/333 Distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another, or 1 subject may have experienced both kinds of events. The 1 participant who was randomized to receive figi and chemo but was treated only with chemo is included under the chemo group. Only treated participants are included.
General disorders Pyrexia	7.7% 26/338 Distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another, or 1 subject may have experienced both kinds of events. The 1 participant who was randomized to receive figi and chemo but was treated only with chemo is included under the chemo group. Only treated participants are included.	9.9% 33/333 Distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another, or 1 subject may have experienced both kinds of events. The 1 participant who was randomized to receive figi and chemo but was treated only with chemo is included under the chemo group. Only treated participants are included.
Investigations Weight decreased	19.2% 65/338 Distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another, or 1 subject may have experienced both kinds of events. The 1 participant who was randomized to receive figi and chemo but was treated only with chemo is included under the chemo group. Only treated participants are included.	8.7% 29/333 Distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another, or 1 subject may have experienced both kinds of events. The 1 participant who was randomized to receive figi and chemo but was treated only with chemo is included under the chemo group. Only treated participants are included.
Metabolism and nutrition disorders Decreased appetite	37.9% 128/338 Distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another, or 1 subject may have experienced both kinds of events. The 1 participant who was randomized to receive figi and chemo but was treated only with chemo is included under the chemo group. Only treated participants are included.	22.5% 75/333 Distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another, or 1 subject may have experienced both kinds of events. The 1 participant who was randomized to receive figi and chemo but was treated only with chemo is included under the chemo group. Only treated participants are included.
Metabolism and nutrition disorders Dehydration	8.3% 28/338 Distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another, or 1 subject may have experienced both kinds of events. The 1 participant who was randomized to receive figi and chemo but was treated only with chemo is included under the chemo group. Only treated participants are included.	3.0% 10/333 Distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another, or 1 subject may have experienced both kinds of events. The 1 participant who was randomized to receive figi and chemo but was treated only with chemo is included under the chemo group. Only treated participants are included.
Metabolism and nutrition disorders Hyperglycaemia	21.9% 74/338 Distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another, or 1 subject may have experienced both kinds of events. The 1 participant who was randomized to receive figi and chemo but was treated only with chemo is included under the chemo group. Only treated participants are included.	4.8% 16/333 Distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another, or 1 subject may have experienced both kinds of events. The 1 participant who was randomized to receive figi and chemo but was treated only with chemo is included under the chemo group. Only treated participants are included.
Metabolism and nutrition disorders Hyperkalaemia	5.0% 17/338 Distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another, or 1 subject may have experienced both kinds of events. The 1 participant who was randomized to receive figi and chemo but was treated only with chemo is included under the chemo group. Only treated participants are included.	1.5% 5/333 Distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another, or 1 subject may have experienced both kinds of events. The 1 participant who was randomized to receive figi and chemo but was treated only with chemo is included under the chemo group. Only treated participants are included.
Musculoskeletal and connective tissue disorders Arthralgia	13.9% 47/338 Distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another, or 1 subject may have experienced both kinds of events. The 1 participant who was randomized to receive figi and chemo but was treated only with chemo is included under the chemo group. Only treated participants are included.	17.1% 57/333 Distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another, or 1 subject may have experienced both kinds of events. The 1 participant who was randomized to receive figi and chemo but was treated only with chemo is included under the chemo group. Only treated participants are included.
Musculoskeletal and connective tissue disorders Back pain	5.6% 19/338 Distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another, or 1 subject may have experienced both kinds of events. The 1 participant who was randomized to receive figi and chemo but was treated only with chemo is included under the chemo group. Only treated participants are included.	5.7% 19/333 Distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another, or 1 subject may have experienced both kinds of events. The 1 participant who was randomized to receive figi and chemo but was treated only with chemo is included under the chemo group. Only treated participants are included.
Musculoskeletal and connective tissue disorders Muscle spasms	5.6% 19/338 Distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another, or 1 subject may have experienced both kinds of events. The 1 participant who was randomized to receive figi and chemo but was treated only with chemo is included under the chemo group. Only treated participants are included.	1.5% 5/333 Distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another, or 1 subject may have experienced both kinds of events. The 1 participant who was randomized to receive figi and chemo but was treated only with chemo is included under the chemo group. Only treated participants are included.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	5.9% 20/338 Distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another, or 1 subject may have experienced both kinds of events. The 1 participant who was randomized to receive figi and chemo but was treated only with chemo is included under the chemo group. Only treated participants are included.	5.1% 17/333 Distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another, or 1 subject may have experienced both kinds of events. The 1 participant who was randomized to receive figi and chemo but was treated only with chemo is included under the chemo group. Only treated participants are included.
Musculoskeletal and connective tissue disorders Myalgia	11.5% 39/338 Distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another, or 1 subject may have experienced both kinds of events. The 1 participant who was randomized to receive figi and chemo but was treated only with chemo is included under the chemo group. Only treated participants are included.	13.2% 44/333 Distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another, or 1 subject may have experienced both kinds of events. The 1 participant who was randomized to receive figi and chemo but was treated only with chemo is included under the chemo group. Only treated participants are included.
Musculoskeletal and connective tissue disorders Pain in extremity	9.8% 33/338 Distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another, or 1 subject may have experienced both kinds of events. The 1 participant who was randomized to receive figi and chemo but was treated only with chemo is included under the chemo group. Only treated participants are included.	6.9% 23/333 Distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another, or 1 subject may have experienced both kinds of events. The 1 participant who was randomized to receive figi and chemo but was treated only with chemo is included under the chemo group. Only treated participants are included.
Nervous system disorders Dizziness	10.9% 37/338 Distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another, or 1 subject may have experienced both kinds of events. The 1 participant who was randomized to receive figi and chemo but was treated only with chemo is included under the chemo group. Only treated participants are included.	9.6% 32/333 Distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another, or 1 subject may have experienced both kinds of events. The 1 participant who was randomized to receive figi and chemo but was treated only with chemo is included under the chemo group. Only treated participants are included.
Nervous system disorders Dysgeusia	7.7% 26/338 Distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another, or 1 subject may have experienced both kinds of events. The 1 participant who was randomized to receive figi and chemo but was treated only with chemo is included under the chemo group. Only treated participants are included.	3.9% 13/333 Distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another, or 1 subject may have experienced both kinds of events. The 1 participant who was randomized to receive figi and chemo but was treated only with chemo is included under the chemo group. Only treated participants are included.
Nervous system disorders Headache	10.9% 37/338 Distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another, or 1 subject may have experienced both kinds of events. The 1 participant who was randomized to receive figi and chemo but was treated only with chemo is included under the chemo group. Only treated participants are included.	6.6% 22/333 Distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another, or 1 subject may have experienced both kinds of events. The 1 participant who was randomized to receive figi and chemo but was treated only with chemo is included under the chemo group. Only treated participants are included.
Nervous system disorders Neuropathy peripheral	18.6% 63/338 Distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another, or 1 subject may have experienced both kinds of events. The 1 participant who was randomized to receive figi and chemo but was treated only with chemo is included under the chemo group. Only treated participants are included.	16.8% 56/333 Distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another, or 1 subject may have experienced both kinds of events. The 1 participant who was randomized to receive figi and chemo but was treated only with chemo is included under the chemo group. Only treated participants are included.
Nervous system disorders Paraesthesia	8.6% 29/338 Distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another, or 1 subject may have experienced both kinds of events. The 1 participant who was randomized to receive figi and chemo but was treated only with chemo is included under the chemo group. Only treated participants are included.	10.5% 35/333 Distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another, or 1 subject may have experienced both kinds of events. The 1 participant who was randomized to receive figi and chemo but was treated only with chemo is included under the chemo group. Only treated participants are included.
Nervous system disorders Peripheral sensory neuropathy	11.8% 40/338 Distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another, or 1 subject may have experienced both kinds of events. The 1 participant who was randomized to receive figi and chemo but was treated only with chemo is included under the chemo group. Only treated participants are included.	15.0% 50/333 Distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another, or 1 subject may have experienced both kinds of events. The 1 participant who was randomized to receive figi and chemo but was treated only with chemo is included under the chemo group. Only treated participants are included.
Psychiatric disorders Anxiety	5.0% 17/338 Distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another, or 1 subject may have experienced both kinds of events. The 1 participant who was randomized to receive figi and chemo but was treated only with chemo is included under the chemo group. Only treated participants are included.	5.1% 17/333 Distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another, or 1 subject may have experienced both kinds of events. The 1 participant who was randomized to receive figi and chemo but was treated only with chemo is included under the chemo group. Only treated participants are included.
Psychiatric disorders Insomnia	9.5% 32/338 Distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another, or 1 subject may have experienced both kinds of events. The 1 participant who was randomized to receive figi and chemo but was treated only with chemo is included under the chemo group. Only treated participants are included.	9.0% 30/333 Distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another, or 1 subject may have experienced both kinds of events. The 1 participant who was randomized to receive figi and chemo but was treated only with chemo is included under the chemo group. Only treated participants are included.
Respiratory, thoracic and mediastinal disorders Cough	19.5% 66/338 Distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another, or 1 subject may have experienced both kinds of events. The 1 participant who was randomized to receive figi and chemo but was treated only with chemo is included under the chemo group. Only treated participants are included.	17.7% 59/333 Distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another, or 1 subject may have experienced both kinds of events. The 1 participant who was randomized to receive figi and chemo but was treated only with chemo is included under the chemo group. Only treated participants are included.
Respiratory, thoracic and mediastinal disorders Dyspnoea	16.6% 56/338 Distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another, or 1 subject may have experienced both kinds of events. The 1 participant who was randomized to receive figi and chemo but was treated only with chemo is included under the chemo group. Only treated participants are included.	19.5% 65/333 Distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another, or 1 subject may have experienced both kinds of events. The 1 participant who was randomized to receive figi and chemo but was treated only with chemo is included under the chemo group. Only treated participants are included.
Respiratory, thoracic and mediastinal disorders Epistaxis	7.7% 26/338 Distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another, or 1 subject may have experienced both kinds of events. The 1 participant who was randomized to receive figi and chemo but was treated only with chemo is included under the chemo group. Only treated participants are included.	0.90% 3/333 Distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another, or 1 subject may have experienced both kinds of events. The 1 participant who was randomized to receive figi and chemo but was treated only with chemo is included under the chemo group. Only treated participants are included.
Respiratory, thoracic and mediastinal disorders Haemoptysis	9.5% 32/338 Distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another, or 1 subject may have experienced both kinds of events. The 1 participant who was randomized to receive figi and chemo but was treated only with chemo is included under the chemo group. Only treated participants are included.	6.3% 21/333 Distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another, or 1 subject may have experienced both kinds of events. The 1 participant who was randomized to receive figi and chemo but was treated only with chemo is included under the chemo group. Only treated participants are included.
Skin and subcutaneous tissue disorders Alopecia	40.8% 138/338 Distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another, or 1 subject may have experienced both kinds of events. The 1 participant who was randomized to receive figi and chemo but was treated only with chemo is included under the chemo group. Only treated participants are included.	43.8% 146/333 Distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another, or 1 subject may have experienced both kinds of events. The 1 participant who was randomized to receive figi and chemo but was treated only with chemo is included under the chemo group. Only treated participants are included.