Trial Outcomes & Findings for TEACO: Taxotere, Eloxatin, Avastin in Cancer of the Ovary (NCT NCT00296816)

Last Updated: 2012-08-23

Results Overview

Tumor assessments were performed by Computed tomography (CT) and Magnetic Resonance Imaging (MRI) to evaluate disease progression based on Gynecologic Oncology Group (GOG) Response Evaluation Criteria in Solid Tumors (RECIST). Disease progression was recorded as any one of the following: * appearance of a new lesion * symptomatic deterioration * progression of target or nontarget lesions * death Participants who did not die or show show disease progression achieved PFS. PFS rate is the percent of participants who achieved PFS.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

132 participants

Primary outcome timeframe

up to 12 months following treatment initiation

Results posted on

2012-08-23

Participant Flow

152 participants were screened for the study. 20 were screen failures. 132 participants met eligibity criteria and were treated with study medication.

Participant milestones

Participant milestones
Measure	Oxaliplatin/Docetaxel/Bevacizumab Participants with International Federation of Gynecology and Obstetrics (FIGO) stage IB through IV ovarian, primary peritoneal, or fallopian tube carcinoma treated with Oxaliplatin, Docetaxel, and Bevacizumab - 28 days after initial surgery
Overall Study STARTED	132
Overall Study COMPLETED	58
Overall Study NOT COMPLETED	74

Reasons for withdrawal

Reasons for withdrawal
Measure	Oxaliplatin/Docetaxel/Bevacizumab Participants with International Federation of Gynecology and Obstetrics (FIGO) stage IB through IV ovarian, primary peritoneal, or fallopian tube carcinoma treated with Oxaliplatin, Docetaxel, and Bevacizumab - 28 days after initial surgery
Overall Study Disease Progression	37
Overall Study Adverse Event	18
Overall Study Investigator/Participant request	5
Overall Study Non-compliance	1
Overall Study Missing for end of treatment	4
Overall Study Progression based on CA-125 (biomarker)	2
Overall Study Poor performance status	1
Overall Study Relocation to Florida	1
Overall Study Noncompliance/decision to discontinue	1
Overall Study Urine protein/creatinine ratio delay	1
Overall Study Neuropathy/patient preference	1
Overall Study Proteinuria	1
Overall Study ineligibility due to radiation treatment	1

Baseline Characteristics

TEACO: Taxotere, Eloxatin, Avastin in Cancer of the Ovary

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Oxaliplatin/Docetaxel/Bevacizumab (Measurable Disease) n=80 Participants Participants with International Federation of Gynecology and Obstetrics (FIGO) stage IB through IV ovarian, primary peritoneal, or fallopian tube carcinoma treated with Oxaliplatin, Docetaxel, and Bevacizumab - 28 days after initial surgery, with a measurable disease at baseline. Measurable disease was defined as having at least one lesion that could be accurately measured in at least one dimension.	Oxaliplatin/Docetaxel/Bevacizumab (Non-Measurable Disease) n=52 Participants Participants with International Federation of Gynecology and Obstetrics (FIGO) stage IB through IV ovarian, primary peritoneal, or fallopian tube carcinoma treated with Oxaliplatin, Docetaxel, and Bevacizumab - 28 days after initial surgery, who did not have a measurable disease at baseline. Measurable disease was defined as having at least one lesion that could be accurately measured in at least one dimension.	Total n=132 Participants Total of all reporting groups
Age Continuous	57.5 years STANDARD_DEVIATION 10.43 • n=5 Participants	60.9 years STANDARD_DEVIATION 9.54 • n=7 Participants	58.8 years STANDARD_DEVIATION 10.19 • n=5 Participants
Sex: Female, Male Female	80 Participants n=5 Participants	52 Participants n=7 Participants	132 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Primary Tumor Site Ovary	65 participants n=5 Participants	45 participants n=7 Participants	110 participants n=5 Participants
Primary Tumor Site Fallopian tube	6 participants n=5 Participants	5 participants n=7 Participants	11 participants n=5 Participants
Primary Tumor Site Peritoneum	9 participants n=5 Participants	2 participants n=7 Participants	11 participants n=5 Participants
FIGO stage at diagnosis Stage IB	0 participants n=5 Participants	0 participants n=7 Participants	0 participants n=5 Participants
FIGO stage at diagnosis Stage IC	0 participants n=5 Participants	3 participants n=7 Participants	3 participants n=5 Participants
FIGO stage at diagnosis Stage IIA	0 participants n=5 Participants	0 participants n=7 Participants	0 participants n=5 Participants
FIGO stage at diagnosis Stage IIB	0 participants n=5 Participants	0 participants n=7 Participants	0 participants n=5 Participants
FIGO stage at diagnosis Stage IIC	3 participants n=5 Participants	5 participants n=7 Participants	8 participants n=5 Participants
FIGO stage at diagnosis Stage IIIA	3 participants n=5 Participants	2 participants n=7 Participants	5 participants n=5 Participants
FIGO stage at diagnosis Stage IIIB	2 participants n=5 Participants	5 participants n=7 Participants	7 participants n=5 Participants
FIGO stage at diagnosis Stage IIIC	57 participants n=5 Participants	32 participants n=7 Participants	89 participants n=5 Participants
FIGO stage at diagnosis Stage IV	15 participants n=5 Participants	5 participants n=7 Participants	20 participants n=5 Participants

PRIMARY outcome

Timeframe: up to 12 months following treatment initiation

Population: Intent-to-treat population with measurable disease at baseline - All participants with measurable disease at baseline who received study drugs, except for participants from one site which was closed prematurely, and for whom efficacy data was not available.

Outcome measures

Outcome measures
Measure	Oxaliplatin/Docetaxel/Bevacizumab n=70 Participants Participants with International Federation of Gynecology and Obstetrics (FIGO) stage IB through IV ovarian, primary peritoneal, or fallopian tube carcinoma treated with Oxaliplatin, Docetaxel, and Bevacizumab - 28 days after initial surgery
Twelve-month Progression-free Survival (PFS) Rate in Participants	65.7 percentage of participants Interval 53.4 to 76.7

SECONDARY outcome

Timeframe: up to 24 months following treatment initiation

Outcome measures

Outcome measures
Measure	Oxaliplatin/Docetaxel/Bevacizumab n=70 Participants Participants with International Federation of Gynecology and Obstetrics (FIGO) stage IB through IV ovarian, primary peritoneal, or fallopian tube carcinoma treated with Oxaliplatin, Docetaxel, and Bevacizumab - 28 days after initial surgery
Twenty Four-month Progression-free Survival (PFS) Rate in Participants	34.3 percentage of participants Interval 23.3 to 46.6

SECONDARY outcome

Timeframe: up to approximately 1300 days following treatment initiation

Time to PFS was the interval from the date of registration to the earliest date of disease progression or death, whichever occurred first. Time of PFS was censored * on the last available tumor assessment date for participants leaving the study prior to disease progression or death; and also for participants requiring off-study medication or additional debulking surgery (where assessment date used was the one prior to off-study medication or surgery), * at Day 1, for living participants with no post-baseline tumor assessments. Median PFS was estimated from a Kaplan-Meier curve.

Outcome measures

Outcome measures
Measure	Oxaliplatin/Docetaxel/Bevacizumab n=70 Participants Participants with International Federation of Gynecology and Obstetrics (FIGO) stage IB through IV ovarian, primary peritoneal, or fallopian tube carcinoma treated with Oxaliplatin, Docetaxel, and Bevacizumab - 28 days after initial surgery
Median Time to Progression-free Survival (PFS)	495 days Interval 384.0 to 596.0

SECONDARY outcome

Timeframe: up to 12 months following treatment initiation

Tumors were assessed by CT and MRI. Tumor response was evaluated by GOG RECIST in which: * Complete response (CR) was the disappearance of all target and non-target lesions, with no evidence of new lesions * Partial response (PR) was at least a 30% decrease in the sum of longest dimensions (LD) of all measurable target lesions Participants with a response (CR or PR) were to have the initial response confirmed by tumor imaging in 4-6 weeks.

Outcome measures

Outcome measures
Measure	Oxaliplatin/Docetaxel/Bevacizumab n=70 Participants Participants with International Federation of Gynecology and Obstetrics (FIGO) stage IB through IV ovarian, primary peritoneal, or fallopian tube carcinoma treated with Oxaliplatin, Docetaxel, and Bevacizumab - 28 days after initial surgery
Tumor Response Rate Based on Gynecologic Oncology Group (GOG) Response Evaluation Criteria in Solid Tumors (RECIST) Confirmed complete response (CR)	21 participants
Tumor Response Rate Based on Gynecologic Oncology Group (GOG) Response Evaluation Criteria in Solid Tumors (RECIST) Confirmed partial response (PR)	20 participants
Tumor Response Rate Based on Gynecologic Oncology Group (GOG) Response Evaluation Criteria in Solid Tumors (RECIST) Unconfirmed response (CR+PR)	51 participants
Tumor Response Rate Based on Gynecologic Oncology Group (GOG) Response Evaluation Criteria in Solid Tumors (RECIST) Unconfirmed complete response (CR)	23 participants
Tumor Response Rate Based on Gynecologic Oncology Group (GOG) Response Evaluation Criteria in Solid Tumors (RECIST) Unconfirmed partial response (PR)	28 participants
Tumor Response Rate Based on Gynecologic Oncology Group (GOG) Response Evaluation Criteria in Solid Tumors (RECIST) Unconfirmed progressive disease (PD)	5 participants
Tumor Response Rate Based on Gynecologic Oncology Group (GOG) Response Evaluation Criteria in Solid Tumors (RECIST) Confirmed response (CR+PR)	41 participants

SECONDARY outcome

Timeframe: up to 12 months following treatment initiation

Population: All participants with non-measurable disease at baseline, except for those at one site that closed prematurely, as their data was not available for efficacy measures.

Participants with Recurrence-free survival (RFS) were participants with a non-measurable disease at baseline, who had not achieved disease progression nor had died. Disease progression included the following: * the appearance of a new lesion * symptomatic deterioration * progression of non-target lesions * a predefined serum CA 125 increase. RFS rate was the percent of participants in the non-measurable disease subgroup who achieved RFS.

Outcome measures

Outcome measures
Measure	Oxaliplatin/Docetaxel/Bevacizumab n=40 Participants Participants with International Federation of Gynecology and Obstetrics (FIGO) stage IB through IV ovarian, primary peritoneal, or fallopian tube carcinoma treated with Oxaliplatin, Docetaxel, and Bevacizumab - 28 days after initial surgery
Twelve-month Recurrence-free Survival (RFS) Rate in Participants With Non Measurable Disease at Baseline	67.5 percentage of participants Interval 50.9 to 81.4

SECONDARY outcome

Timeframe: up to approximately 1500 days following treatment initiation

Population: All participants with non-measurable disease at baseline, except for those at one site that closed prematurely, as their data was not available for efficacy measures.

The time to RFS was programmatically defined as the interval from the date of registration to the earliest date of disease progression or death, whichever occurred first. Participants were * censored on the last available CA 125 biomarker blood draw date if * left the study prior to disease progression or death * they received off-study anti-tumor medication * underwent debulking surgery * censored at Day 1 if they were alive had no post baseline CA 125 biomarker blood draw.

Outcome measures

Outcome measures
Measure	Oxaliplatin/Docetaxel/Bevacizumab n=40 Participants Participants with International Federation of Gynecology and Obstetrics (FIGO) stage IB through IV ovarian, primary peritoneal, or fallopian tube carcinoma treated with Oxaliplatin, Docetaxel, and Bevacizumab - 28 days after initial surgery
Median Time to Recurrence-free Survival (RFS) in Participants With Non-measurable Disease at Baseline	631 days Interval 427.0 to Some participants did not show recurrence and were living, therefore the upper limit is not applicable

SECONDARY outcome

Timeframe: up to 12 months after treatment initiation

Population: All participants with non-measurable and measurable disease at baseline, and a pretreatment sample that was at least twice the ULN value for CA-125 within 2 weeks of first study treatment.

A CA-125 response was considered at least a 50% reduction in the level of the biomarker, CA-125, from a pretreatment level, which was confirmed and maintained for at least 28 days. The overall CA-125 biomarker response rate was defined as the number of participants in the measurable disease subgroup who met the above criteria at least once within the study treatment period +21 days, divided by the number of evaluable participants in the disease subgroup.

Outcome measures

Outcome measures
Measure	Oxaliplatin/Docetaxel/Bevacizumab n=80 Participants Participants with International Federation of Gynecology and Obstetrics (FIGO) stage IB through IV ovarian, primary peritoneal, or fallopian tube carcinoma treated with Oxaliplatin, Docetaxel, and Bevacizumab - 28 days after initial surgery
CA-125 Response Rate With non-measurable disease at baseline (N=27)	81.5 percentage of participants Interval 61.9 to 93.7
CA-125 Response Rate With measurable disease at baseline (N=53)	83.0 percentage of participants Interval 70.2 to 91.9

SECONDARY outcome

Timeframe: up to up to approximately 1700 days after treatment initiation

Population: Intent-to-treat population - All participants who received study drugs, except for participants from one site which was closed prematurely, and for whom efficacy data was not available.

Survival was the observed length of life from entry into the study to death or the date of last contact. The overall survival rate (percentage of participants showing survival) at 12 and 24-months is reported here.

Outcome measures

Outcome measures
Measure	Oxaliplatin/Docetaxel/Bevacizumab n=110 Participants Participants with International Federation of Gynecology and Obstetrics (FIGO) stage IB through IV ovarian, primary peritoneal, or fallopian tube carcinoma treated with Oxaliplatin, Docetaxel, and Bevacizumab - 28 days after initial surgery
Overall Survival Rate Overall survival at 12 months	85.5 percentage of participants Interval 77.5 to 91.5
Overall Survival Rate Overall survival at 24 months	71.8 percentage of participants Interval 62.4 to 80.0

SECONDARY outcome

Timeframe: up to approximately 1700 days after treatment initiation

Population: Intent-to-treat population - All participants who received study drugs, except for participants from one site which was closed prematurely, and for whom efficacy data was not available.

Survival was the observed length of life from entry into the study to death or the date of last contact. The median overall survival time was estimated using Kaplan-Meier Curve.

Outcome measures

Outcome measures
Measure	Oxaliplatin/Docetaxel/Bevacizumab n=110 Participants Participants with International Federation of Gynecology and Obstetrics (FIGO) stage IB through IV ovarian, primary peritoneal, or fallopian tube carcinoma treated with Oxaliplatin, Docetaxel, and Bevacizumab - 28 days after initial surgery
Median Overall Survival Time	1437.0 days Interval 1036.0 to Some participants were living, therefore the upper limit is not applicable

Adverse Events

Oxaliplatin/Docetaxel/Bevacizumab

Serious events: 33 serious events

Other events: 130 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Oxaliplatin/Docetaxel/Bevacizumab n=132 participants at risk Participants with International Federation of Gynecology and Obstetrics (FIGO) stage IB through IV ovarian, primary peritoneal, or fallopian tube carcinoma treated with Oxaliplatin, Docetaxel, and Bevacizumab - 28 days after initial surgery
Blood and lymphatic system disorders Febrile neutropenia	3.0% 4/132 AEs were collected up to 30 days after the administration of the last study dose.
Blood and lymphatic system disorders Neutropenia	0.76% 1/132 AEs were collected up to 30 days after the administration of the last study dose.
Cardiac disorders Cardiac failure congestive	0.76% 1/132 AEs were collected up to 30 days after the administration of the last study dose.
Cardiac disorders Supraventricular tachycardia	0.76% 1/132 AEs were collected up to 30 days after the administration of the last study dose.
Ear and labyrinth disorders Vertigo positional	0.76% 1/132 AEs were collected up to 30 days after the administration of the last study dose.
Gastrointestinal disorders Nausea	5.3% 7/132 AEs were collected up to 30 days after the administration of the last study dose.
Gastrointestinal disorders Vomiting	5.3% 7/132 AEs were collected up to 30 days after the administration of the last study dose.
Gastrointestinal disorders Small intestinal obstruction	3.8% 5/132 AEs were collected up to 30 days after the administration of the last study dose.
Gastrointestinal disorders Abdominal pain	2.3% 3/132 AEs were collected up to 30 days after the administration of the last study dose.
Gastrointestinal disorders Abdominal pain lower	0.76% 1/132 AEs were collected up to 30 days after the administration of the last study dose.
Gastrointestinal disorders Abdominal pain upper	0.76% 1/132 AEs were collected up to 30 days after the administration of the last study dose.
Gastrointestinal disorders Colitis	0.76% 1/132 AEs were collected up to 30 days after the administration of the last study dose.
Gastrointestinal disorders Colonic fistula	0.76% 1/132 AEs were collected up to 30 days after the administration of the last study dose.
Gastrointestinal disorders Diarrhoea	0.76% 1/132 AEs were collected up to 30 days after the administration of the last study dose.
Gastrointestinal disorders Gastrointestinal haemorrhage	0.76% 1/132 AEs were collected up to 30 days after the administration of the last study dose.
Gastrointestinal disorders Haematemesis	0.76% 1/132 AEs were collected up to 30 days after the administration of the last study dose.
Gastrointestinal disorders Ileus	0.76% 1/132 AEs were collected up to 30 days after the administration of the last study dose.
Gastrointestinal disorders Intestinal obstruction	0.76% 1/132 AEs were collected up to 30 days after the administration of the last study dose.
Gastrointestinal disorders Intestinal perforation	0.76% 1/132 AEs were collected up to 30 days after the administration of the last study dose.
Gastrointestinal disorders Peritoneal adhesions	0.76% 1/132 AEs were collected up to 30 days after the administration of the last study dose.
General disorders Fatigue	0.76% 1/132 AEs were collected up to 30 days after the administration of the last study dose.
General disorders Non-cardiac chest pain	0.76% 1/132 AEs were collected up to 30 days after the administration of the last study dose.
General disorders Oedema peripheral	0.76% 1/132 AEs were collected up to 30 days after the administration of the last study dose.
General disorders Pain	0.76% 1/132 AEs were collected up to 30 days after the administration of the last study dose.
General disorders Pyrexia	0.76% 1/132 AEs were collected up to 30 days after the administration of the last study dose.
Hepatobiliary disorders Bile duct obstruction	0.76% 1/132 AEs were collected up to 30 days after the administration of the last study dose.
Hepatobiliary disorders Cholangitis	0.76% 1/132 AEs were collected up to 30 days after the administration of the last study dose.
Hepatobiliary disorders Portal vein thrombosis	0.76% 1/132 AEs were collected up to 30 days after the administration of the last study dose.
Infections and infestations Abdominal abscess	0.76% 1/132 AEs were collected up to 30 days after the administration of the last study dose.
Infections and infestations Pneumonia	0.76% 1/132 AEs were collected up to 30 days after the administration of the last study dose.
Infections and infestations Urinary tract infection	0.76% 1/132 AEs were collected up to 30 days after the administration of the last study dose.
Infections and infestations Wound infection	0.76% 1/132 AEs were collected up to 30 days after the administration of the last study dose.
Injury, poisoning and procedural complications Subdural haematoma	0.76% 1/132 AEs were collected up to 30 days after the administration of the last study dose.
Metabolism and nutrition disorders Dehydration	2.3% 3/132 AEs were collected up to 30 days after the administration of the last study dose.
Metabolism and nutrition disorders Decreased appetite	0.76% 1/132 AEs were collected up to 30 days after the administration of the last study dose.
Metabolism and nutrition disorders Hypoglycaemia	0.76% 1/132 AEs were collected up to 30 days after the administration of the last study dose.
Nervous system disorders Encephalopathy	0.76% 1/132 AEs were collected up to 30 days after the administration of the last study dose.
Nervous system disorders Transient ischaemic attack	0.76% 1/132 AEs were collected up to 30 days after the administration of the last study dose.
Renal and urinary disorders Cystitis haemorrhagic	0.76% 1/132 AEs were collected up to 30 days after the administration of the last study dose.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	3.8% 5/132 AEs were collected up to 30 days after the administration of the last study dose.
Vascular disorders Hypertension	0.76% 1/132 AEs were collected up to 30 days after the administration of the last study dose.
Vascular disorders Poor venous access	0.76% 1/132 AEs were collected up to 30 days after the administration of the last study dose.
Vascular disorders Venous thrombosis	0.76% 1/132 AEs were collected up to 30 days after the administration of the last study dose.

Other adverse events

Other adverse events
Measure	Oxaliplatin/Docetaxel/Bevacizumab n=132 participants at risk Participants with International Federation of Gynecology and Obstetrics (FIGO) stage IB through IV ovarian, primary peritoneal, or fallopian tube carcinoma treated with Oxaliplatin, Docetaxel, and Bevacizumab - 28 days after initial surgery
Blood and lymphatic system disorders Neutropenia	44.7% 59/132 AEs were collected up to 30 days after the administration of the last study dose.
Blood and lymphatic system disorders Leukopenia	23.5% 31/132 AEs were collected up to 30 days after the administration of the last study dose.
Blood and lymphatic system disorders Anaemia	13.6% 18/132 AEs were collected up to 30 days after the administration of the last study dose.
Blood and lymphatic system disorders Lymphopenia	9.8% 13/132 AEs were collected up to 30 days after the administration of the last study dose.
Eye disorders Lacrimation increased	26.5% 35/132 AEs were collected up to 30 days after the administration of the last study dose.
Eye disorders Vision blurred	7.6% 10/132 AEs were collected up to 30 days after the administration of the last study dose.
Gastrointestinal disorders Nausea	64.4% 85/132 AEs were collected up to 30 days after the administration of the last study dose.
Gastrointestinal disorders Diarrhoea	58.3% 77/132 AEs were collected up to 30 days after the administration of the last study dose.
Gastrointestinal disorders Constipation	44.7% 59/132 AEs were collected up to 30 days after the administration of the last study dose.
Gastrointestinal disorders Vomiting	31.8% 42/132 AEs were collected up to 30 days after the administration of the last study dose.
Gastrointestinal disorders Abdominal pain	28.0% 37/132 AEs were collected up to 30 days after the administration of the last study dose.
Gastrointestinal disorders Stomatitis	19.7% 26/132 AEs were collected up to 30 days after the administration of the last study dose.
Gastrointestinal disorders Abdominal discomfort	8.3% 11/132 AEs were collected up to 30 days after the administration of the last study dose.
Gastrointestinal disorders Abdominal pain lower	7.6% 10/132 AEs were collected up to 30 days after the administration of the last study dose.
Gastrointestinal disorders Dysphagia	7.6% 10/132 AEs were collected up to 30 days after the administration of the last study dose.
Gastrointestinal disorders Gingival bleeding	7.6% 10/132 AEs were collected up to 30 days after the administration of the last study dose.
Gastrointestinal disorders Oral pain	7.6% 10/132 AEs were collected up to 30 days after the administration of the last study dose.
Gastrointestinal disorders Abdominal distension	6.1% 8/132 AEs were collected up to 30 days after the administration of the last study dose.
Gastrointestinal disorders Dyspepsia	6.1% 8/132 AEs were collected up to 30 days after the administration of the last study dose.
Gastrointestinal disorders Flatulence	6.1% 8/132 AEs were collected up to 30 days after the administration of the last study dose.
Gastrointestinal disorders Abdominal pain upper	5.3% 7/132 AEs were collected up to 30 days after the administration of the last study dose.
General disorders Fatigue	76.5% 101/132 AEs were collected up to 30 days after the administration of the last study dose.
General disorders Oedema peripheral	14.4% 19/132 AEs were collected up to 30 days after the administration of the last study dose.
General disorders Asthenia	9.1% 12/132 AEs were collected up to 30 days after the administration of the last study dose.
General disorders Pain	9.1% 12/132 AEs were collected up to 30 days after the administration of the last study dose.
General disorders Malaise	8.3% 11/132 AEs were collected up to 30 days after the administration of the last study dose.
General disorders Pyrexia	7.6% 10/132 AEs were collected up to 30 days after the administration of the last study dose.
General disorders Chest pain	6.8% 9/132 AEs were collected up to 30 days after the administration of the last study dose.
General disorders Mucosal inflammation	6.8% 9/132 AEs were collected up to 30 days after the administration of the last study dose.
General disorders Temperature intolerance	6.8% 9/132 AEs were collected up to 30 days after the administration of the last study dose.
Immune system disorders Hypersensitivity	6.1% 8/132 AEs were collected up to 30 days after the administration of the last study dose.
Infections and infestations Urinary tract infection	22.7% 30/132 AEs were collected up to 30 days after the administration of the last study dose.
Infections and infestations Upper respiratory tract infection	10.6% 14/132 AEs were collected up to 30 days after the administration of the last study dose.
Infections and infestations Sinusitis	8.3% 11/132 AEs were collected up to 30 days after the administration of the last study dose.
Infections and infestations Rhinitis	7.6% 10/132 AEs were collected up to 30 days after the administration of the last study dose.
Infections and infestations Nasopharyngitis	5.3% 7/132 AEs were collected up to 30 days after the administration of the last study dose.
Investigations Alanine aminotransferase increased	9.1% 12/132 AEs were collected up to 30 days after the administration of the last study dose.
Investigations Aspartate aminotransferase increased	9.1% 12/132 AEs were collected up to 30 days after the administration of the last study dose.
Investigations Neutrophil count	9.1% 12/132 AEs were collected up to 30 days after the administration of the last study dose.
Investigations Blood alkaline phosphatase increased	7.6% 10/132 AEs were collected up to 30 days after the administration of the last study dose.
Investigations Weight decreased	5.3% 7/132 AEs were collected up to 30 days after the administration of the last study dose.
Metabolism and nutrition disorders Decreased appetite	33.3% 44/132 AEs were collected up to 30 days after the administration of the last study dose.
Metabolism and nutrition disorders Hypokalaemia	8.3% 11/132 AEs were collected up to 30 days after the administration of the last study dose.
Metabolism and nutrition disorders Dehydration	5.3% 7/132 AEs were collected up to 30 days after the administration of the last study dose.
Musculoskeletal and connective tissue disorders Arthralgia	35.6% 47/132 AEs were collected up to 30 days after the administration of the last study dose.
Musculoskeletal and connective tissue disorders Back pain	19.7% 26/132 AEs were collected up to 30 days after the administration of the last study dose.
Musculoskeletal and connective tissue disorders Myalgia	17.4% 23/132 AEs were collected up to 30 days after the administration of the last study dose.
Musculoskeletal and connective tissue disorders Pain in extremity	12.1% 16/132 AEs were collected up to 30 days after the administration of the last study dose.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	10.6% 14/132 AEs were collected up to 30 days after the administration of the last study dose.
Musculoskeletal and connective tissue disorders Bone pain	9.8% 13/132 AEs were collected up to 30 days after the administration of the last study dose.
Musculoskeletal and connective tissue disorders Muscle spasms	5.3% 7/132 AEs were collected up to 30 days after the administration of the last study dose.
Nervous system disorders Neuropathy peripheral	48.5% 64/132 AEs were collected up to 30 days after the administration of the last study dose.
Nervous system disorders Headache	30.3% 40/132 AEs were collected up to 30 days after the administration of the last study dose.
Nervous system disorders Peripheral sensory neuropathy	25.0% 33/132 AEs were collected up to 30 days after the administration of the last study dose.
Nervous system disorders Dysgeusia	23.5% 31/132 AEs were collected up to 30 days after the administration of the last study dose.
Nervous system disorders Paraesthesia	19.7% 26/132 AEs were collected up to 30 days after the administration of the last study dose.
Nervous system disorders Dizziness	18.2% 24/132 AEs were collected up to 30 days after the administration of the last study dose.
Nervous system disorders Hypoaesthesia	6.1% 8/132 AEs were collected up to 30 days after the administration of the last study dose.
Psychiatric disorders Insomnia	15.2% 20/132 AEs were collected up to 30 days after the administration of the last study dose.
Psychiatric disorders Depression	14.4% 19/132 AEs were collected up to 30 days after the administration of the last study dose.
Psychiatric disorders Anxiety	6.8% 9/132 AEs were collected up to 30 days after the administration of the last study dose.
Renal and urinary disorders Proteinuria	8.3% 11/132 AEs were collected up to 30 days after the administration of the last study dose.
Renal and urinary disorders Dysuria	7.6% 10/132 AEs were collected up to 30 days after the administration of the last study dose.
Reproductive system and breast disorders Vaginal haemorrhage	5.3% 7/132 AEs were collected up to 30 days after the administration of the last study dose.
Respiratory, thoracic and mediastinal disorders Epistaxis	29.5% 39/132 AEs were collected up to 30 days after the administration of the last study dose.
Respiratory, thoracic and mediastinal disorders Cough	14.4% 19/132 AEs were collected up to 30 days after the administration of the last study dose.
Respiratory, thoracic and mediastinal disorders Dyspnoea	14.4% 19/132 AEs were collected up to 30 days after the administration of the last study dose.
Respiratory, thoracic and mediastinal disorders Dysphonia	9.1% 12/132 AEs were collected up to 30 days after the administration of the last study dose.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	7.6% 10/132 AEs were collected up to 30 days after the administration of the last study dose.
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	7.6% 10/132 AEs were collected up to 30 days after the administration of the last study dose.
Skin and subcutaneous tissue disorders Alopecia	65.2% 86/132 AEs were collected up to 30 days after the administration of the last study dose.
Skin and subcutaneous tissue disorders Nail disorder	25.0% 33/132 AEs were collected up to 30 days after the administration of the last study dose.
Skin and subcutaneous tissue disorders Rash	12.9% 17/132 AEs were collected up to 30 days after the administration of the last study dose.
Skin and subcutaneous tissue disorders Dry skin	11.4% 15/132 AEs were collected up to 30 days after the administration of the last study dose.
Skin and subcutaneous tissue disorders Nail discolouration	6.8% 9/132 AEs were collected up to 30 days after the administration of the last study dose.
Skin and subcutaneous tissue disorders Pruritus	5.3% 7/132 AEs were collected up to 30 days after the administration of the last study dose.
Vascular disorders Hypertension	23.5% 31/132 AEs were collected up to 30 days after the administration of the last study dose.
Vascular disorders Flushing	10.6% 14/132 AEs were collected up to 30 days after the administration of the last study dose.
Vascular disorders Hot flush	7.6% 10/132 AEs were collected up to 30 days after the administration of the last study dose.

Additional Information

Trial Trans[parency Team

Sanofi

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The sponsor encourages the publication of the results of their studies, using only clean, checked and validated data in order to ensure the accuracy of the results. At least 45 days in advance of proposed submission, the Investigator should forward a copy of the manuscript or abstract for review by the sponsor, and, if necessary, delay publication or communication for a limited time in order to protect the confidentiality or proprietary nature of any information contained therein.
Publication restrictions are in place

Restriction type: OTHER