Trial Outcomes & Findings for A Continuation Study Using Sunitinib Malate For Patients Leaving Treatment On A Previous Sunitinib Study. (NCT NCT00428220)

Last Updated: 2019-06-27

Results Overview

Assessment of AEs included type, incidence, severity (graded by the National Cancer Institute \[NCI\] Common Terminology Criteria for Adverse Events \[CTCAE\], Version 3.0, timing, seriousness, and relatedness; and laboratory abnormalities.

Recruitment status

COMPLETED

Study phase

Target enrollment

223 participants

Primary outcome timeframe

From first day of treatment on the current study up to 28 days post the last dose of study treatment

Results posted on

2019-06-27

Participant Flow

In this open-label extension study, access to sunitinib was provided to participants who had participated in a previous parent study and who had been judged by the Investigator to have likely clinical benefit from continuing sunitinib dosing.

Participants receiving sunitinib in previous studies began treatment in this study with the last dose they were taking in the parent or extension study. Participants were to continue to access sunitinib on this protocol as long as there was evidence of disease control and/or clinical benefit in the judgment of the Investigator.

Participant milestones

Participant milestones
Measure	Sunitinib Participants receiving treatment on single-agent sunitinib on continuous dosing regimens returned for study visits at Day 28, and every 8 weeks thereafter. Participants on regimens other than single-agent sunitinib on continuous dosing followed the schedule of activities from their parent or extension protocol. Sunitinib-naïve participants (ie, those not treated with sunitinib in the previous parent study) received a starting dose of 37.5 mg sunitinib once daily.
Overall Study STARTED	223
Overall Study COMPLETED	0
Overall Study NOT COMPLETED	223

Reasons for withdrawal

Reasons for withdrawal
Measure	Sunitinib Participants receiving treatment on single-agent sunitinib on continuous dosing regimens returned for study visits at Day 28, and every 8 weeks thereafter. Participants on regimens other than single-agent sunitinib on continuous dosing followed the schedule of activities from their parent or extension protocol. Sunitinib-naïve participants (ie, those not treated with sunitinib in the previous parent study) received a starting dose of 37.5 mg sunitinib once daily.
Overall Study Participant died	8
Overall Study Global deterioration of health status	7
Overall Study Lost to Follow-up	4
Overall Study Objective progression or relapse	123
Overall Study Participant refused continued treatment	7
Overall Study Adverse Event	51
Overall Study Other	23

Baseline Characteristics

A Continuation Study Using Sunitinib Malate For Patients Leaving Treatment On A Previous Sunitinib Study.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Sunitinib n=223 Participants Participants receiving treatment on single-agent sunitinib on continuous dosing regimens returned for study visits at Day 28, and every 8 weeks thereafter. Participants on regimens other than single-agent sunitinib on continuous dosing followed the schedule of activities from their parent or extension protocol. Sunitinib-naïve participants (ie, those not treated with sunitinib in the previous parent study) received a starting dose of 37.5 mg sunitinib once daily.
Age, Continuous	55.2 years STANDARD_DEVIATION 12.5 • n=5 Participants
Sex: Female, Male Female	130 Participants n=5 Participants
Sex: Female, Male Male	93 Participants n=5 Participants

PRIMARY outcome

Timeframe: From first day of treatment on the current study up to 28 days post the last dose of study treatment

Population: The safety population was defined as all participants enrolled in the study who received at least one dose of study drug in this study.

Outcome measures

Outcome measures
Measure	Sunitinib n=223 Participants Participants receiving treatment on single-agent sunitinib on continuous dosing regimens returned for study visits at Day 28, and every 8 weeks thereafter. Participants on regimens other than single-agent sunitinib on continuous dosing followed the schedule of activities from their parent or extension protocol. Sunitinib-naïve participants (ie, those not treated with sunitinib in the previous parent study) received a starting dose of 37.5 mg sunitinib once daily.	Sunitinib 2 Parent Study: A6181087	Sunitinib 3 Parent Study: A6181094	Sunitinib 4 Parent Study: A6181107	Sunitinib 5 Parent Study: A6181110	Sunitinib 6 Parent Study: A6181111	Sunitinib 7 Parent Study: A6181112	Sunitinib 8 Parent Study: A6181113	Sunitinib 9 Parent Study: A6181120	Sunitinib 10 Parent Study: A6181126	Sunitinib 11 Parent Study: A6181170
Number of Participants With Treatment-emergent Adverse Events (AEs) (All Causalities) Temporary discontinuations due to AEs	146 participants	—	—	—	—	—	—	—	—	—	—
Number of Participants With Treatment-emergent Adverse Events (AEs) (All Causalities) Participants with adverse events (AE)	221 participants	—	—	—	—	—	—	—	—	—	—
Number of Participants With Treatment-emergent Adverse Events (AEs) (All Causalities) Participants with serious adverse events (SAE)	90 participants	—	—	—	—	—	—	—	—	—	—
Number of Participants With Treatment-emergent Adverse Events (AEs) (All Causalities) Participants with grade 3 or 4 AEs	174 participants	—	—	—	—	—	—	—	—	—	—
Number of Participants With Treatment-emergent Adverse Events (AEs) (All Causalities) Participants with grade 5 AEs	24 participants	—	—	—	—	—	—	—	—	—	—
Number of Participants With Treatment-emergent Adverse Events (AEs) (All Causalities) Participants discontinued due to AEs	67 participants	—	—	—	—	—	—	—	—	—	—
Number of Participants With Treatment-emergent Adverse Events (AEs) (All Causalities) Participants with dose reduction due to AEs	66 participants	—	—	—	—	—	—	—	—	—	—

PRIMARY outcome

Timeframe: From first day of treatment on the current study up to 28 days post the last dose of study treatment

Population: The safety population was defined as all participants enrolled in the study who received at least one dose of study drug in this study.

Outcome measures

Outcome measures
Measure	Sunitinib n=223 Participants Participants receiving treatment on single-agent sunitinib on continuous dosing regimens returned for study visits at Day 28, and every 8 weeks thereafter. Participants on regimens other than single-agent sunitinib on continuous dosing followed the schedule of activities from their parent or extension protocol. Sunitinib-naïve participants (ie, those not treated with sunitinib in the previous parent study) received a starting dose of 37.5 mg sunitinib once daily.	Sunitinib 2 Parent Study: A6181087	Sunitinib 3 Parent Study: A6181094	Sunitinib 4 Parent Study: A6181107	Sunitinib 5 Parent Study: A6181110	Sunitinib 6 Parent Study: A6181111	Sunitinib 7 Parent Study: A6181112	Sunitinib 8 Parent Study: A6181113	Sunitinib 9 Parent Study: A6181120	Sunitinib 10 Parent Study: A6181126	Sunitinib 11 Parent Study: A6181170
Number of Participants With Treatment-emergent AEs (Treatment-Related) Participants discontinued due to AEs	29 participants	—	—	—	—	—	—	—	—	—	—
Number of Participants With Treatment-emergent AEs (Treatment-Related) Participants with AE	217 participants	—	—	—	—	—	—	—	—	—	—
Number of Participants With Treatment-emergent AEs (Treatment-Related) Participants with SAE	39 participants	—	—	—	—	—	—	—	—	—	—
Number of Participants With Treatment-emergent AEs (Treatment-Related) Participants with grade 3 or 4 AEs	146 participants	—	—	—	—	—	—	—	—	—	—
Number of Participants With Treatment-emergent AEs (Treatment-Related) Participants with grade 5 AEs	0 participants	—	—	—	—	—	—	—	—	—	—
Number of Participants With Treatment-emergent AEs (Treatment-Related) Participants with dose reduction due to AEs	64 participants	—	—	—	—	—	—	—	—	—	—
Number of Participants With Treatment-emergent AEs (Treatment-Related) Temporary discontinuations due to AEs	135 participants	—	—	—	—	—	—	—	—	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: From the first day of treatment in parent study until last day of treatment in A6181114 study.

Population: The safety population was defined as all participants enrolled in the study who received at least one dose of study drug in this study.

Duration of clinical benefit is defined as the length of time participants remain on sunitinib from the first day of treatment on the parent protocol until the end of sunitinib treatment in this study (A6181114). For participants who were on placebo or a comparator drug in the parent study, duration of clinical benefit is defined as the length of time participants are on sunitinib in this study.

Outcome measures

Outcome measures
Measure	Sunitinib n=3 Participants Participants receiving treatment on single-agent sunitinib on continuous dosing regimens returned for study visits at Day 28, and every 8 weeks thereafter. Participants on regimens other than single-agent sunitinib on continuous dosing followed the schedule of activities from their parent or extension protocol. Sunitinib-naïve participants (ie, those not treated with sunitinib in the previous parent study) received a starting dose of 37.5 mg sunitinib once daily.	Sunitinib 2 n=1 Participants Parent Study: A6181087	Sunitinib 3 n=2 Participants Parent Study: A6181094	Sunitinib 4 n=69 Participants Parent Study: A6181107	Sunitinib 5 n=38 Participants Parent Study: A6181110	Sunitinib 6 n=95 Participants Parent Study: A6181111	Sunitinib 7 n=8 Participants Parent Study: A6181112	Sunitinib 8 n=1 Participants Parent Study: A6181113	Sunitinib 9 n=3 Participants Parent Study: A6181120	Sunitinib 10 n=1 Participants Parent Study: A6181126	Sunitinib 11 n=2 Participants Parent Study: A6181170
Summary of Duration of Clinical Benefit	186.6 Weeks Standard Deviation 68.2	76.0 Weeks Standard Deviation NA Only one datum, hence no standard deviation.	157.5 Weeks Standard Deviation 6.2	22.1 Weeks Standard Deviation 25.2	122.9 Weeks Standard Deviation 73.4	76.6 Weeks Standard Deviation 69.0	71.6 Weeks Standard Deviation 26.2	198.9 Weeks Standard Deviation NA Only one datum, hence no standard deviation.	142.2 Weeks Standard Deviation 23.6	183.6 Weeks Standard Deviation NA Only one datum, hence no standard deviation.	227.5 Weeks Standard Deviation 57.9

Adverse Events

Sunitinib

Serious events: 90 serious events

Other events: 219 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Sunitinib n=223 participants at risk Participants receiving treatment on single-agent sunitinib on continuous dosing regimens returned for study visits at Day 28, and every 8 weeks thereafter. Participants on regimens other than single-agent sunitinib on continuous dosing followed the schedule of activities from their parent or extension protocol. Sunitinib-naïve participants (ie, those not treated with sunitinib in the previous parent study) received a starting dose of 37.5 mg sunitinib once daily.
Blood and lymphatic system disorders Anaemia	2.2% 5/223 • From first day of treatment on the current study up to 28 days post the last dose of study treatment The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Blood and lymphatic system disorders Neutropenia	0.45% 1/223 • From first day of treatment on the current study up to 28 days post the last dose of study treatment The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Blood and lymphatic system disorders Thrombocytopenia	0.45% 1/223 • From first day of treatment on the current study up to 28 days post the last dose of study treatment The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Cardiac disorders Acute coronary syndrome	0.45% 1/223 • From first day of treatment on the current study up to 28 days post the last dose of study treatment The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Cardiac disorders Acute myocardial infarction	0.45% 1/223 • From first day of treatment on the current study up to 28 days post the last dose of study treatment The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Cardiac disorders Myocardial infarction	0.45% 1/223 • From first day of treatment on the current study up to 28 days post the last dose of study treatment The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Abdominal adhesions	0.45% 1/223 • From first day of treatment on the current study up to 28 days post the last dose of study treatment The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Abdominal pain	3.6% 8/223 • From first day of treatment on the current study up to 28 days post the last dose of study treatment The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Abdominal pain upper	0.90% 2/223 • From first day of treatment on the current study up to 28 days post the last dose of study treatment The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Ascites	0.90% 2/223 • From first day of treatment on the current study up to 28 days post the last dose of study treatment The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Diarrhoea	2.7% 6/223 • From first day of treatment on the current study up to 28 days post the last dose of study treatment The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Duodenitis	0.45% 1/223 • From first day of treatment on the current study up to 28 days post the last dose of study treatment The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Gastritis	0.45% 1/223 • From first day of treatment on the current study up to 28 days post the last dose of study treatment The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Gastrointestinal haemorrhage	0.90% 2/223 • From first day of treatment on the current study up to 28 days post the last dose of study treatment The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Haematemesis	0.90% 2/223 • From first day of treatment on the current study up to 28 days post the last dose of study treatment The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Inguinal hernia	0.45% 1/223 • From first day of treatment on the current study up to 28 days post the last dose of study treatment The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Intestinal perforation	0.45% 1/223 • From first day of treatment on the current study up to 28 days post the last dose of study treatment The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Mallory-weiss syndrome	0.45% 1/223 • From first day of treatment on the current study up to 28 days post the last dose of study treatment The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Nausea	1.3% 3/223 • From first day of treatment on the current study up to 28 days post the last dose of study treatment The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Oesophagitis	0.45% 1/223 • From first day of treatment on the current study up to 28 days post the last dose of study treatment The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Pancreatitis	0.90% 2/223 • From first day of treatment on the current study up to 28 days post the last dose of study treatment The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Peritoneal haemorrhage	0.45% 1/223 • From first day of treatment on the current study up to 28 days post the last dose of study treatment The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Pneumatosis intestinalis	0.45% 1/223 • From first day of treatment on the current study up to 28 days post the last dose of study treatment The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Small intestinal obstruction	0.45% 1/223 • From first day of treatment on the current study up to 28 days post the last dose of study treatment The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Subileus	0.45% 1/223 • From first day of treatment on the current study up to 28 days post the last dose of study treatment The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Vomiting	3.1% 7/223 • From first day of treatment on the current study up to 28 days post the last dose of study treatment The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
General disorders Asthenia	1.3% 3/223 • From first day of treatment on the current study up to 28 days post the last dose of study treatment The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
General disorders Chest pain	0.90% 2/223 • From first day of treatment on the current study up to 28 days post the last dose of study treatment The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
General disorders Disease progression	5.4% 12/223 • From first day of treatment on the current study up to 28 days post the last dose of study treatment The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
General disorders Fatigue	0.45% 1/223 • From first day of treatment on the current study up to 28 days post the last dose of study treatment The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
General disorders Gait disturbance	0.45% 1/223 • From first day of treatment on the current study up to 28 days post the last dose of study treatment The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
General disorders General physical health deterioration	2.2% 5/223 • From first day of treatment on the current study up to 28 days post the last dose of study treatment The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
General disorders Generalised oedema	0.45% 1/223 • From first day of treatment on the current study up to 28 days post the last dose of study treatment The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
General disorders Mucosal inflammation	0.45% 1/223 • From first day of treatment on the current study up to 28 days post the last dose of study treatment The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
General disorders Oedema	0.45% 1/223 • From first day of treatment on the current study up to 28 days post the last dose of study treatment The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
General disorders Pyrexia	2.2% 5/223 • From first day of treatment on the current study up to 28 days post the last dose of study treatment The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
General disorders Sudden death	0.45% 1/223 • From first day of treatment on the current study up to 28 days post the last dose of study treatment The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Hepatobiliary disorders Biliary colic	0.45% 1/223 • From first day of treatment on the current study up to 28 days post the last dose of study treatment The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Hepatobiliary disorders Cholangitis	0.45% 1/223 • From first day of treatment on the current study up to 28 days post the last dose of study treatment The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Hepatobiliary disorders Cholecystitis acute	0.90% 2/223 • From first day of treatment on the current study up to 28 days post the last dose of study treatment The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Hepatobiliary disorders Hepatic failure	0.45% 1/223 • From first day of treatment on the current study up to 28 days post the last dose of study treatment The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Hepatobiliary disorders Jaundice	0.90% 2/223 • From first day of treatment on the current study up to 28 days post the last dose of study treatment The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Hepatobiliary disorders Jaundice cholestatic	0.45% 1/223 • From first day of treatment on the current study up to 28 days post the last dose of study treatment The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Infections and infestations Bronchitis	0.45% 1/223 • From first day of treatment on the current study up to 28 days post the last dose of study treatment The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Infections and infestations Gastroenteritis	0.45% 1/223 • From first day of treatment on the current study up to 28 days post the last dose of study treatment The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Infections and infestations Infection	0.45% 1/223 • From first day of treatment on the current study up to 28 days post the last dose of study treatment The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Infections and infestations Lymphangitis	0.45% 1/223 • From first day of treatment on the current study up to 28 days post the last dose of study treatment The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Infections and infestations Pneumonia	0.90% 2/223 • From first day of treatment on the current study up to 28 days post the last dose of study treatment The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Infections and infestations Pneumonia bacterial	0.45% 1/223 • From first day of treatment on the current study up to 28 days post the last dose of study treatment The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Infections and infestations Sepsis	0.45% 1/223 • From first day of treatment on the current study up to 28 days post the last dose of study treatment The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Infections and infestations Urinary tract infection	0.90% 2/223 • From first day of treatment on the current study up to 28 days post the last dose of study treatment The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Injury, poisoning and procedural complications Joint dislocation	0.45% 1/223 • From first day of treatment on the current study up to 28 days post the last dose of study treatment The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Injury, poisoning and procedural complications Pelvic fracture	0.45% 1/223 • From first day of treatment on the current study up to 28 days post the last dose of study treatment The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Injury, poisoning and procedural complications Road traffic accident	0.45% 1/223 • From first day of treatment on the current study up to 28 days post the last dose of study treatment The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Injury, poisoning and procedural complications Ulna fracture	0.45% 1/223 • From first day of treatment on the current study up to 28 days post the last dose of study treatment The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Investigations Alanine aminotransferase increased	0.45% 1/223 • From first day of treatment on the current study up to 28 days post the last dose of study treatment The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Investigations Blood calcium increased	0.45% 1/223 • From first day of treatment on the current study up to 28 days post the last dose of study treatment The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Investigations Ejection fraction decreased	0.45% 1/223 • From first day of treatment on the current study up to 28 days post the last dose of study treatment The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Investigations Weight decreased	0.45% 1/223 • From first day of treatment on the current study up to 28 days post the last dose of study treatment The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Metabolism and nutrition disorders Acidosis	0.45% 1/223 • From first day of treatment on the current study up to 28 days post the last dose of study treatment The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Metabolism and nutrition disorders Decreased appetite	1.3% 3/223 • From first day of treatment on the current study up to 28 days post the last dose of study treatment The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Metabolism and nutrition disorders Dehydration	0.90% 2/223 • From first day of treatment on the current study up to 28 days post the last dose of study treatment The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Metabolism and nutrition disorders Hypoglycaemia	0.45% 1/223 • From first day of treatment on the current study up to 28 days post the last dose of study treatment The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Infections and infestations Urosepsis	0.45% 1/223 • From first day of treatment on the current study up to 28 days post the last dose of study treatment The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Musculoskeletal and connective tissue disorders Arthralgia	1.8% 4/223 • From first day of treatment on the current study up to 28 days post the last dose of study treatment The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Musculoskeletal and connective tissue disorders Back pain	1.3% 3/223 • From first day of treatment on the current study up to 28 days post the last dose of study treatment The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Musculoskeletal and connective tissue disorders Flank pain	0.45% 1/223 • From first day of treatment on the current study up to 28 days post the last dose of study treatment The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Musculoskeletal and connective tissue disorders Intervertebral disc protrusion	0.45% 1/223 • From first day of treatment on the current study up to 28 days post the last dose of study treatment The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Musculoskeletal and connective tissue disorders Osteonecrosis of jaw	0.45% 1/223 • From first day of treatment on the current study up to 28 days post the last dose of study treatment The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Musculoskeletal and connective tissue disorders Pain in extremity	0.45% 1/223 • From first day of treatment on the current study up to 28 days post the last dose of study treatment The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Basal cell carcinoma	0.45% 1/223 • From first day of treatment on the current study up to 28 days post the last dose of study treatment The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer	0.45% 1/223 • From first day of treatment on the current study up to 28 days post the last dose of study treatment The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Chronic myeloid leukaemia	0.45% 1/223 • From first day of treatment on the current study up to 28 days post the last dose of study treatment The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Infected neoplasm	0.45% 1/223 • From first day of treatment on the current study up to 28 days post the last dose of study treatment The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lymphangiosis carcinomatosa	0.45% 1/223 • From first day of treatment on the current study up to 28 days post the last dose of study treatment The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate cancer	0.45% 1/223 • From first day of treatment on the current study up to 28 days post the last dose of study treatment The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumour haemorrhage	0.45% 1/223 • From first day of treatment on the current study up to 28 days post the last dose of study treatment The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Nervous system disorders Convulsion	0.45% 1/223 • From first day of treatment on the current study up to 28 days post the last dose of study treatment The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Nervous system disorders Encephalopathy	0.45% 1/223 • From first day of treatment on the current study up to 28 days post the last dose of study treatment The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Nervous system disorders Hepatic encephalopathy	0.45% 1/223 • From first day of treatment on the current study up to 28 days post the last dose of study treatment The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Nervous system disorders Lethargy	0.45% 1/223 • From first day of treatment on the current study up to 28 days post the last dose of study treatment The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Nervous system disorders Metabolic encephalopathy	0.45% 1/223 • From first day of treatment on the current study up to 28 days post the last dose of study treatment The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Psychiatric disorders Confusional state	0.45% 1/223 • From first day of treatment on the current study up to 28 days post the last dose of study treatment The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Psychiatric disorders Depression	0.45% 1/223 • From first day of treatment on the current study up to 28 days post the last dose of study treatment The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Psychiatric disorders Mental status changes	0.45% 1/223 • From first day of treatment on the current study up to 28 days post the last dose of study treatment The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Psychiatric disorders Suicide attempt	0.45% 1/223 • From first day of treatment on the current study up to 28 days post the last dose of study treatment The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Renal and urinary disorders Renal failure	0.45% 1/223 • From first day of treatment on the current study up to 28 days post the last dose of study treatment The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Renal and urinary disorders Renal failure acute	0.90% 2/223 • From first day of treatment on the current study up to 28 days post the last dose of study treatment The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Reproductive system and breast disorders Scrotal erythema	0.45% 1/223 • From first day of treatment on the current study up to 28 days post the last dose of study treatment The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Respiratory, thoracic and mediastinal disorders Cough	0.45% 1/223 • From first day of treatment on the current study up to 28 days post the last dose of study treatment The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Respiratory, thoracic and mediastinal disorders Dyspnoea	1.3% 3/223 • From first day of treatment on the current study up to 28 days post the last dose of study treatment The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Respiratory, thoracic and mediastinal disorders Epistaxis	0.90% 2/223 • From first day of treatment on the current study up to 28 days post the last dose of study treatment The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Respiratory, thoracic and mediastinal disorders Lung disorder	0.45% 1/223 • From first day of treatment on the current study up to 28 days post the last dose of study treatment The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.45% 1/223 • From first day of treatment on the current study up to 28 days post the last dose of study treatment The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Respiratory, thoracic and mediastinal disorders Pneumothorax	0.90% 2/223 • From first day of treatment on the current study up to 28 days post the last dose of study treatment The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.90% 2/223 • From first day of treatment on the current study up to 28 days post the last dose of study treatment The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.45% 1/223 • From first day of treatment on the current study up to 28 days post the last dose of study treatment The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Skin and subcutaneous tissue disorders Rash	0.45% 1/223 • From first day of treatment on the current study up to 28 days post the last dose of study treatment The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Skin and subcutaneous tissue disorders Skin exfoliation	0.45% 1/223 • From first day of treatment on the current study up to 28 days post the last dose of study treatment The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Vascular disorders Aortic dissection	0.45% 1/223 • From first day of treatment on the current study up to 28 days post the last dose of study treatment The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Vascular disorders Hypertension	0.45% 1/223 • From first day of treatment on the current study up to 28 days post the last dose of study treatment The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Vascular disorders Pelvic venous thrombosis	0.45% 1/223 • From first day of treatment on the current study up to 28 days post the last dose of study treatment The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Vascular disorders Thrombosis	0.45% 1/223 • From first day of treatment on the current study up to 28 days post the last dose of study treatment The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Vascular disorders Venous thrombosis limb	0.45% 1/223 • From first day of treatment on the current study up to 28 days post the last dose of study treatment The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Investigations Lipase increased	0.45% 1/223 • From first day of treatment on the current study up to 28 days post the last dose of study treatment The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.

Other adverse events

Other adverse events
Measure	Sunitinib n=223 participants at risk Participants receiving treatment on single-agent sunitinib on continuous dosing regimens returned for study visits at Day 28, and every 8 weeks thereafter. Participants on regimens other than single-agent sunitinib on continuous dosing followed the schedule of activities from their parent or extension protocol. Sunitinib-naïve participants (ie, those not treated with sunitinib in the previous parent study) received a starting dose of 37.5 mg sunitinib once daily.
Blood and lymphatic system disorders Anaemia	18.4% 41/223 • From first day of treatment on the current study up to 28 days post the last dose of study treatment The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Blood and lymphatic system disorders Leukopenia	15.7% 35/223 • From first day of treatment on the current study up to 28 days post the last dose of study treatment The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Blood and lymphatic system disorders Neutropenia	34.1% 76/223 • From first day of treatment on the current study up to 28 days post the last dose of study treatment The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Blood and lymphatic system disorders Thrombocytopenia	25.6% 57/223 • From first day of treatment on the current study up to 28 days post the last dose of study treatment The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Endocrine disorders Hypothyroidism	10.8% 24/223 • From first day of treatment on the current study up to 28 days post the last dose of study treatment The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Eye disorders Lacrimation increased	5.8% 13/223 • From first day of treatment on the current study up to 28 days post the last dose of study treatment The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Abdominal distention	9.0% 20/223 • From first day of treatment on the current study up to 28 days post the last dose of study treatment The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Abdominal pain	27.8% 62/223 • From first day of treatment on the current study up to 28 days post the last dose of study treatment The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Abdominal pain upper	20.6% 46/223 • From first day of treatment on the current study up to 28 days post the last dose of study treatment The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Constipation	18.4% 41/223 • From first day of treatment on the current study up to 28 days post the last dose of study treatment The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Diarrhoea	63.7% 142/223 • From first day of treatment on the current study up to 28 days post the last dose of study treatment The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Dry mouth	6.3% 14/223 • From first day of treatment on the current study up to 28 days post the last dose of study treatment The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Dyspepsia	16.1% 36/223 • From first day of treatment on the current study up to 28 days post the last dose of study treatment The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Gastritis	5.8% 13/223 • From first day of treatment on the current study up to 28 days post the last dose of study treatment The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Gastrooesophageal reflux disease	6.3% 14/223 • From first day of treatment on the current study up to 28 days post the last dose of study treatment The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Haemorrhoids	5.8% 13/223 • From first day of treatment on the current study up to 28 days post the last dose of study treatment The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Nausea	34.5% 77/223 • From first day of treatment on the current study up to 28 days post the last dose of study treatment The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Stomatitis	17.5% 39/223 • From first day of treatment on the current study up to 28 days post the last dose of study treatment The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Vomiting	27.4% 61/223 • From first day of treatment on the current study up to 28 days post the last dose of study treatment The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
General disorders Asthenia	30.0% 67/223 • From first day of treatment on the current study up to 28 days post the last dose of study treatment The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
General disorders Chest pain	6.3% 14/223 • From first day of treatment on the current study up to 28 days post the last dose of study treatment The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
General disorders Face oedema	7.6% 17/223 • From first day of treatment on the current study up to 28 days post the last dose of study treatment The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
General disorders Fatigue	37.2% 83/223 • From first day of treatment on the current study up to 28 days post the last dose of study treatment The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
General disorders Mucosal inflammation	26.0% 58/223 • From first day of treatment on the current study up to 28 days post the last dose of study treatment The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
General disorders Oedema peripheral	13.5% 30/223 • From first day of treatment on the current study up to 28 days post the last dose of study treatment The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
General disorders Pain	5.8% 13/223 • From first day of treatment on the current study up to 28 days post the last dose of study treatment The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
General disorders Pyrexia	11.7% 26/223 • From first day of treatment on the current study up to 28 days post the last dose of study treatment The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Infections and infestations Gingivitis	5.4% 12/223 • From first day of treatment on the current study up to 28 days post the last dose of study treatment The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Infections and infestations Nasopharyngitis	8.1% 18/223 • From first day of treatment on the current study up to 28 days post the last dose of study treatment The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Infections and infestations Upper respiratory tract infection	7.6% 17/223 • From first day of treatment on the current study up to 28 days post the last dose of study treatment The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Investigations Alanine aminotransferase increased	9.4% 21/223 • From first day of treatment on the current study up to 28 days post the last dose of study treatment The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Investigations Aspartate aminotransferase increased	6.7% 15/223 • From first day of treatment on the current study up to 28 days post the last dose of study treatment The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Investigations Blood creatinine increased	5.8% 13/223 • From first day of treatment on the current study up to 28 days post the last dose of study treatment The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Investigations Haemoglobin decreased	9.0% 20/223 • From first day of treatment on the current study up to 28 days post the last dose of study treatment The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Investigations Neutrophil count decreased	7.2% 16/223 • From first day of treatment on the current study up to 28 days post the last dose of study treatment The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Investigations Platelet count decreased	8.5% 19/223 • From first day of treatment on the current study up to 28 days post the last dose of study treatment The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Investigations Weight decreased	16.1% 36/223 • From first day of treatment on the current study up to 28 days post the last dose of study treatment The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Metabolism and nutrition disorders Decreased appetite	34.1% 76/223 • From first day of treatment on the current study up to 28 days post the last dose of study treatment The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Metabolism and nutrition disorders Hyperglycaemia	5.8% 13/223 • From first day of treatment on the current study up to 28 days post the last dose of study treatment The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Metabolism and nutrition disorders Hypoalbuminaemia	5.4% 12/223 • From first day of treatment on the current study up to 28 days post the last dose of study treatment The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Musculoskeletal and connective tissue disorders Arthralgia	13.9% 31/223 • From first day of treatment on the current study up to 28 days post the last dose of study treatment The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Musculoskeletal and connective tissue disorders Back pain	21.1% 47/223 • From first day of treatment on the current study up to 28 days post the last dose of study treatment The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Musculoskeletal and connective tissue disorders Bone pain	5.4% 12/223 • From first day of treatment on the current study up to 28 days post the last dose of study treatment The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Musculoskeletal and connective tissue disorders Muscle spasms	8.1% 18/223 • From first day of treatment on the current study up to 28 days post the last dose of study treatment The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Musculoskeletal and connective tissue disorders Myalgia	10.8% 24/223 • From first day of treatment on the current study up to 28 days post the last dose of study treatment The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Musculoskeletal and connective tissue disorders Pain in extremity	16.1% 36/223 • From first day of treatment on the current study up to 28 days post the last dose of study treatment The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Nervous system disorders Dizziness	7.2% 16/223 • From first day of treatment on the current study up to 28 days post the last dose of study treatment The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Nervous system disorders Dysgeusia	26.9% 60/223 • From first day of treatment on the current study up to 28 days post the last dose of study treatment The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Psychiatric disorders Depression	6.3% 14/223 • From first day of treatment on the current study up to 28 days post the last dose of study treatment The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Psychiatric disorders Insomnia	15.7% 35/223 • From first day of treatment on the current study up to 28 days post the last dose of study treatment The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Respiratory, thoracic and mediastinal disorders Cough	15.7% 35/223 • From first day of treatment on the current study up to 28 days post the last dose of study treatment The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Respiratory, thoracic and mediastinal disorders Dyspnoea	19.7% 44/223 • From first day of treatment on the current study up to 28 days post the last dose of study treatment The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Respiratory, thoracic and mediastinal disorders Epistaxis	19.3% 43/223 • From first day of treatment on the current study up to 28 days post the last dose of study treatment The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	8.5% 19/223 • From first day of treatment on the current study up to 28 days post the last dose of study treatment The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Respiratory, thoracic and mediastinal disorders Pleural effusion	6.3% 14/223 • From first day of treatment on the current study up to 28 days post the last dose of study treatment The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Skin and subcutaneous tissue disorders Alopecia	7.6% 17/223 • From first day of treatment on the current study up to 28 days post the last dose of study treatment The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Skin and subcutaneous tissue disorders Dry skin	9.4% 21/223 • From first day of treatment on the current study up to 28 days post the last dose of study treatment The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Skin and subcutaneous tissue disorders Erythema	8.5% 19/223 • From first day of treatment on the current study up to 28 days post the last dose of study treatment The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Skin and subcutaneous tissue disorders Hair colour changes	24.7% 55/223 • From first day of treatment on the current study up to 28 days post the last dose of study treatment The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Skin and subcutaneous tissue disorders Hyperkeratosis	5.8% 13/223 • From first day of treatment on the current study up to 28 days post the last dose of study treatment The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Skin and subcutaneous tissue disorders Palmar-plantar erythrodysaesthesia syndrome	37.2% 83/223 • From first day of treatment on the current study up to 28 days post the last dose of study treatment The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Nervous system disorders Headache	19.7% 44/223 • From first day of treatment on the current study up to 28 days post the last dose of study treatment The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Skin and subcutaneous tissue disorders Rash	13.5% 30/223 • From first day of treatment on the current study up to 28 days post the last dose of study treatment The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Skin and subcutaneous tissue disorders Skin discolouration	11.7% 26/223 • From first day of treatment on the current study up to 28 days post the last dose of study treatment The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Skin and subcutaneous tissue disorders Yellow skin	9.9% 22/223 • From first day of treatment on the current study up to 28 days post the last dose of study treatment The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Vascular disorders Hypertension	28.7% 64/223 • From first day of treatment on the current study up to 28 days post the last dose of study treatment The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.

Additional Information

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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.
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