TAK-951

Percentage of participants with complete response, defined as no emesis (vomiting or retching) and no need for rescue therapy (indicated if vomiting/retching and/or nausea score ≥4 or upon participant's request) were reported. The severity of nausea was scored using a self-reported, 11-point numerical Verbal Rating Scale (VRS), where 0 represents no nausea and 10 represents the worst nausea possible. Significant nausea was defined as a VRS score ≥4. Percentages are rounded off to whole number at the nearest single decimal.

Physical examination included the examination of the abdomen; extremities; head, eyes, ears, nose (HEENT); neurological; skin and mucosae; thorax.

The criteria for markedly abnormal values of vital signs' parameters were: Pulse Rate (beats/minute) \<50 and \>120; Systolic Blood Pressure \[millimeters of mercury (mmHg)\] \<85 and \>180; Diastolic Blood Pressure (mmHg) \<50 and \>110; Temperature \[degrees Celsius (C)\] \<35.6 and \>37.7. Only categories with atleast one participant with events are reported.

The criteria for markedly abnormal values of 12-lead ECG parameters were: ECG Mean Heart Rate (beats/min) \<50 beats per minute and \>120 beats per minute; PR Interval, Aggregate \[milliseconds (msec)\] \<=80 msec and \>=200 msec; QRS Duration, Aggregate (msec) \<=80 msec and \>=120 msec; QT Interval with Fridericia Correction Method (QTcF) Interval, Aggregate (msec) \>=500 msec or \>=30 msec change from Baseline and \>=450 msec. Only categories with atleast one participant with event are reported.

The laboratory parameters of chemistry, and hematology were assessed. Clinical laboratory tests included serum chemistry, hematology, and urinalysis. MAV criteria: Alanine aminotransferase(U/L) \>3xupper limit of normal(ULN); Albumin\<2.5g/dL,\<25g/L; Alkaline phosphatase (U/L)\>3 x ULN; Aspartate aminotransferase (U/L)\>3 x ULN; Bilirubin\>1.5mg/dL, \>34.2 µmol/L; Calcium\<8.0 mg/dL,LLN-\<2.0mmol/L, \>1.0mmol/L; Carbon dioxide \<8.0 (mmol/L); Chloride\<75 mmol/L,\>126 mmol/L; Creatinine\>177µmol/L; Gamma glutamyl transferase (U/L)\>2.0 mg/dL, \>3.0 x ULN; Glucose\<3 mmol/L,\>10 mmol/L; Potassium\<3.0 mmol/L \>5.5 mmol/L; Protein(g/L)\<0.8 x LLN \>1.2 x ULN; Sodium\<130mmol/L \>150mmol/L; Urea nitrogen \>10.7; Erythrocytes 10\^12erythrocytes/L) \<0.8 x LLN,\>1.2 x ULN; Hematocrit(%) \<0.8 x LLN,\>1.2xULN; Hemoglobin(g/L)\<0.8 x LLN, \>1.2 x ULN; Leukocytes(10\^9 leukocytes/L)\<0.5 x LLN \>1.5 x ULN; platelets(10\^9 platelets/L)\<75-\>600. Only categories with atleast one participant with event are reported.

An adverse event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (example, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A TEAE was defined as an adverse event which occurred on or after the first dose of study drug and no more than 30 days after the last dose of study drug.